<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408716</url>
  </required_header>
  <id_info>
    <org_study_id>REDUCE-IT Study</org_study_id>
    <nct_id>NCT04408716</nct_id>
  </id_info>
  <brief_title>Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings</brief_title>
  <official_title>Risk of Asymptomatic Cerebral Embolism During Atrial Fibrillation Ablation Using Smart Touch SF Catheter With Ablation Index Guided High-power Short-duration Strategy Versus Smart Touch Catheter With Standard Settings Evaluated by High-resolution Diffusion-weighted Magnetic Resonance Imaging Technique (REDUCE-IT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective randomized controlled study is to evaluate the risk of&#xD;
      asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with&#xD;
      AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of&#xD;
      asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted&#xD;
      magnetic resonance imaging technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and&#xD;
      persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is&#xD;
      associated with the occurrence of procedure-related thromboembolic events, especially the&#xD;
      risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted&#xD;
      magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration&#xD;
      (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an&#xD;
      increasingly used technique for catheter ablation of AF, which is proposed to be associated&#xD;
      with relatively wider and superficial lesions, less risk of esophageal injury, and shorter&#xD;
      procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the&#xD;
      advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip&#xD;
      irrigation system, which is a wide-spread distribution of the irrigating solution (56&#xD;
      irrigation holes), resulting in homogenous cooling and protection from thrombus formation and&#xD;
      reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation&#xD;
      technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much&#xD;
      lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced&#xD;
      STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective&#xD;
      randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during&#xD;
      catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation&#xD;
      settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">September 13, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is a single center prospective single-blinded randomized controlled trial. Enrolled AF patients planning clinically-indicated catheter ablation is randomly assigned with 1:1 ratio to undergo catheter ablation with ablation index guided high-power short-duration strategy or the standard radiofrequency ablation technique. Besides the evaluation at baseline, all the participants will be followed up at 24-72 hours, 1 month and 3 months post ablation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.</measure>
    <time_frame>Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.</time_frame>
    <description>The brain hDWI should be performed within 3 days prior to the ablation procedure to investigate previous cerebral lesions and reevaluated within 24-72 hours post ablation to determine the occurrence of new asymptomatic cerebral embolic lesions. The acute cerebral embolic lesion is typically defined as a new focal hyper-intense area detected on the diffusion-weighted sequence, and a hyper-intense signal intensity in the fluid-attenuated inversion recovery sequence, and meantime confirmed by apparent diffusion coefficient mapping as corresponding area of restricted diffusion to rule out a shine-through artifact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.</measure>
    <time_frame>On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.</time_frame>
    <description>The Montreal Cognitive Assessment (MoCA) is known as a brief cognitive screening tool with a high sensitivity and specificity for detecting a mild cognitive impairment. All enrolled patients undergo a prospective assessment of their cognitive function using the MoCA test at 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall complication rate during catheter ablation and up to 3 months follow up.</measure>
    <time_frame>3 months after the catheter ablation procedure.</time_frame>
    <description>Overall complication rate after catheter ablation of AF.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Ablation Index Guided High-Power Short-Duration Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients assigned to undergo AF ablation with ablation index guided high-power short-duration strategy, point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Radiofrequency Ablation Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients assigned to undergo AF ablation with standard radiofrequency ablation group, point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ablation Index Guided High-Power Short-Duration Strategy</intervention_name>
    <description>Point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).</description>
    <arm_group_label>Ablation Index Guided High-Power Short-Duration Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Radiofrequency Ablation Technique</intervention_name>
    <description>Point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).</description>
    <arm_group_label>Standard Radiofrequency Ablation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients≥18 years of age prior to obtaining the written informed consent.&#xD;
&#xD;
          2. Patients with electrocardiographically documented, symptomatic atrial fibrillation.&#xD;
&#xD;
          3. Patients is scheduled to undergo circumferential pulmonary vein antrum radiofrequency&#xD;
             ablation.&#xD;
&#xD;
          4. Patient or patient's legal representative is able and willing to give informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Moderate to severe valvular heart disease.&#xD;
&#xD;
          2. Contraindication for anticoagulation therapy.&#xD;
&#xD;
          3. Contraindication for Diffusion-Weighted MRI.&#xD;
&#xD;
          4. Ischemic stroke or transient ischemic attack within 6 months prior to the consent&#xD;
             date.&#xD;
&#xD;
          5. Acute coronary syndrome within 3 months prior to the consent date.&#xD;
&#xD;
          6. Prior left atrial appendage occlusion device.&#xD;
&#xD;
          7. Prior septal occlusion device.&#xD;
&#xD;
          8. Left atrial size greater than 55 mm.&#xD;
&#xD;
          9. Conditions that prevent patient's participation in neurocognitive assessment (at&#xD;
             physician's discretion).&#xD;
&#xD;
         10. Female patients who are pregnant or breast feeding or plan a pregnancy during the&#xD;
             course of the study.&#xD;
&#xD;
         11. Simultaneous participation in another study.&#xD;
&#xD;
         12. Unwilling or unable to comply fully with the study procedures and follow-up&#xD;
             requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhiyu Ling, PhD</last_name>
    <phone>+8613512362075</phone>
    <email>cardiologyzhiyu@hospital.cqmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Weijie Chen, PhD</last_name>
    <phone>+8619942331069</phone>
    <email>cqmucwj@hospital.cqmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Second Affilliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiyu Ling, PhD</last_name>
      <phone>+8613512362075</phone>
      <email>cardiologyzhiyu@hospital.cqmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Weijie Chen, PhD</last_name>
      <phone>+8619942331069</phone>
      <email>cqmucwj@hospital.cqmu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Qingsong Xiong</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Schmidt B, Szeplaki G, Merkely B, Kautzner J, van Driel V, Bourier F, Kuniss M, Bulava A, Nolker G, Khan M, Lewalter T, Klein N, Wenzel B, Chun JK, Shah D. Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study. J Cardiovasc Electrophysiol. 2019 Jun;30(6):877-885. doi: 10.1111/jce.13902. Epub 2019 Mar 25.</citation>
    <PMID>30848001</PMID>
  </reference>
  <reference>
    <citation>Yu Y, Wang X, Li X, Zhou X, Liao S, Yang W, Yu J, Zhang F, Ju W, Chen H, Yang G, Li M, Gu K, Tang L, Xu Y, Chan JY, Kojodjojo P, Cao K, Fan J, Yang B, Chen M. Higher Incidence of Asymptomatic Cerebral Emboli After Atrial Fibrillation Ablation Found With High-Resolution Diffusion-Weighted Magnetic Resonance Imaging. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007548. doi: 10.1161/CIRCEP.119.007548. Epub 2020 Jan 14.</citation>
    <PMID>31937118</PMID>
  </reference>
  <reference>
    <citation>Providencia R, Albenque JP, Boveda S. The unfinished issue of ischaemic stroke and embolic events during catheter ablation of atrial fibrillation. Europace. 2017 May 1;19(5):881. doi: 10.1093/europace/euw027. No abstract available.</citation>
    <PMID>28340141</PMID>
  </reference>
  <reference>
    <citation>Yamane T. Silent Cerebral Embolism After Catheter Ablation for Atrial Fibrillation - Unresolved Issue or Too Much Concern? Circ J. 2016;80(4):814-5. doi: 10.1253/circj.CJ-16-0186. Epub 2016 Mar 7. No abstract available.</citation>
    <PMID>26948985</PMID>
  </reference>
  <reference>
    <citation>Kyriakopoulou M, Wielandts JY, Strisciuglio T, El Haddad M, Pooter J, Almorad A, Hilfiker G, Phlips T, Unger P, Lycke M, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Evaluation of higher power delivery during RF pulmonary vein isolation using optimized and contiguous lesions. J Cardiovasc Electrophysiol. 2020 May;31(5):1091-1098. doi: 10.1111/jce.14438. Epub 2020 Mar 18.</citation>
    <PMID>32147899</PMID>
  </reference>
  <reference>
    <citation>Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.</citation>
    <PMID>31713704</PMID>
  </reference>
  <reference>
    <citation>Okamatsu H, Koyama J, Sakai Y, Negishi K, Hayashi K, Tsurugi T, Tanaka Y, Nakao K, Sakamoto T, Okumura K. High-power application is associated with shorter procedure time and higher rate of first-pass pulmonary vein isolation in ablation index-guided atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2751-2758. doi: 10.1111/jce.14223. Epub 2019 Oct 21.</citation>
    <PMID>31600006</PMID>
  </reference>
  <reference>
    <citation>Chen S, Schmidt B, Bordignon S, Urbanek L, Tohoku S, Bologna F, Angelkov L, Garvanski I, Tsianakas N, Konstantinou A, Trolese L, Weise F, Perrotta L, Chun KRJ. Ablation index-guided 50 W ablation for pulmonary vein isolation in patients with atrial fibrillation: Procedural data, lesion analysis, and initial results from the FAFA AI High Power Study. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2724-2731. doi: 10.1111/jce.14219. Epub 2019 Oct 13.</citation>
    <PMID>31588620</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Yuehui Yin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Asymptomatic Cerebral Embolism</keyword>
  <keyword>radiofrequency ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Embolism</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408716
org study id: REDUCE-IT Study
nct id: NCT04408716
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this prospective randomized controlled study is to evaluate the risk of
      asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with
      AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of
      asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted
      magnetic resonance imaging technique.
Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and
      persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is
      associated with the occurrence of procedure-related thromboembolic events, especially the
      risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted
      magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration
      (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an
      increasingly used technique for catheter ablation of AF, which is proposed to be associated
      with relatively wider and superficial lesions, less risk of esophageal injury, and shorter
      procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the
      advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip
      irrigation system, which is a wide-spread distribution of the irrigating solution (56
      irrigation holes), resulting in homogenous cooling and protection from thrombus formation and
      reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation
      technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much
      lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced
      STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective
      randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during
      catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation
      settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a single center prospective single-blinded randomized controlled trial. Enrolled AF patients planning clinically-indicated catheter ablation is randomly assigned with 1:1 ratio to undergo catheter ablation with ablation index guided high-power short-duration strategy or the standard radiofrequency ablation technique. Besides the evaluation at baseline, all the participants will be followed up at 24-72 hours, 1 month and 3 months post ablation.
primary purpose: Treatment
masking: Single (Participant)
measure: The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.
time frame: Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.
description: The brain hDWI should be performed within 3 days prior to the ablation procedure to investigate previous cerebral lesions and reevaluated within 24-72 hours post ablation to determine the occurrence of new asymptomatic cerebral embolic lesions. The acute cerebral embolic lesion is typically defined as a new focal hyper-intense area detected on the diffusion-weighted sequence, and a hyper-intense signal intensity in the fluid-attenuated inversion recovery sequence, and meantime confirmed by apparent diffusion coefficient mapping as corresponding area of restricted diffusion to rule out a shine-through artifact.
measure: Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.
time frame: On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.
description: The Montreal Cognitive Assessment (MoCA) is known as a brief cognitive screening tool with a high sensitivity and specificity for detecting a mild cognitive impairment. All enrolled patients undergo a prospective assessment of their cognitive function using the MoCA test at 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.
measure: Overall complication rate during catheter ablation and up to 3 months follow up.
time frame: 3 months after the catheter ablation procedure.
description: Overall complication rate after catheter ablation of AF.
arm group label: Ablation Index Guided High-Power Short-Duration Group
arm group type: Experimental
description: For patients assigned to undergo AF ablation with ablation index guided high-power short-duration strategy, point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
arm group label: Standard Radiofrequency Ablation Group
arm group type: Active Comparator
description: For patients assigned to undergo AF ablation with standard radiofrequency ablation group, point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
intervention type: Procedure
intervention name: Ablation Index Guided High-Power Short-Duration Strategy
description: Point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
arm group label: Ablation Index Guided High-Power Short-Duration Group
intervention type: Procedure
intervention name: Standard Radiofrequency Ablation Technique
description: Point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
arm group label: Standard Radiofrequency Ablation Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhiyu Ling, PhD
phone: +8613512362075
email: cardiologyzhiyu@hospital.cqmu.edu.cn
last name: Weijie Chen, PhD
phone: +8619942331069
email: cqmucwj@hospital.cqmu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
citation: Schmidt B, Szeplaki G, Merkely B, Kautzner J, van Driel V, Bourier F, Kuniss M, Bulava A, Nolker G, Khan M, Lewalter T, Klein N, Wenzel B, Chun JK, Shah D. Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study. J Cardiovasc Electrophysiol. 2019 Jun;30(6):877-885. doi: 10.1111/jce.13902. Epub 2019 Mar 25.
PMID: 30848001
citation: Yu Y, Wang X, Li X, Zhou X, Liao S, Yang W, Yu J, Zhang F, Ju W, Chen H, Yang G, Li M, Gu K, Tang L, Xu Y, Chan JY, Kojodjojo P, Cao K, Fan J, Yang B, Chen M. Higher Incidence of Asymptomatic Cerebral Emboli After Atrial Fibrillation Ablation Found With High-Resolution Diffusion-Weighted Magnetic Resonance Imaging. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007548. doi: 10.1161/CIRCEP.119.007548. Epub 2020 Jan 14.
PMID: 31937118
citation: Providencia R, Albenque JP, Boveda S. The unfinished issue of ischaemic stroke and embolic events during catheter ablation of atrial fibrillation. Europace. 2017 May 1;19(5):881. doi: 10.1093/europace/euw027. No abstract available.
PMID: 28340141
citation: Yamane T. Silent Cerebral Embolism After Catheter Ablation for Atrial Fibrillation - Unresolved Issue or Too Much Concern? Circ J. 2016;80(4):814-5. doi: 10.1253/circj.CJ-16-0186. Epub 2016 Mar 7. No abstract available.
PMID: 26948985
citation: Kyriakopoulou M, Wielandts JY, Strisciuglio T, El Haddad M, Pooter J, Almorad A, Hilfiker G, Phlips T, Unger P, Lycke M, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Evaluation of higher power delivery during RF pulmonary vein isolation using optimized and contiguous lesions. J Cardiovasc Electrophysiol. 2020 May;31(5):1091-1098. doi: 10.1111/jce.14438. Epub 2020 Mar 18.
PMID: 32147899
citation: Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.
PMID: 31713704
citation: Okamatsu H, Koyama J, Sakai Y, Negishi K, Hayashi K, Tsurugi T, Tanaka Y, Nakao K, Sakamoto T, Okumura K. High-power application is associated with shorter procedure time and higher rate of first-pass pulmonary vein isolation in ablation index-guided atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2751-2758. doi: 10.1111/jce.14223. Epub 2019 Oct 21.
PMID: 31600006
citation: Chen S, Schmidt B, Bordignon S, Urbanek L, Tohoku S, Bologna F, Angelkov L, Garvanski I, Tsianakas N, Konstantinou A, Trolese L, Weise F, Perrotta L, Chun KRJ. Ablation index-guided 50 W ablation for pulmonary vein isolation in patients with atrial fibrillation: Procedural data, lesion analysis, and initial results from the FAFA AI High Power Study. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2724-2731. doi: 10.1111/jce.14219. Epub 2019 Oct 13.
PMID: 31588620
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital of Chongqing Medical University
investigator full name: Yuehui Yin
investigator title: Professor
mesh term: Intracranial Embolism
mesh term: Atrial Fibrillation
mesh term: Embolism
sharing ipd: No