<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/NCT03819504</url>
  </required_header>
  <id_info>
    <org_study_id>STAR-VT</org_study_id>
    <secondary_id>NV19-02-00212</secondary_id>
    <nct_id>NCT03819504</nct_id>
  </id_info>
  <brief_title>Stereotactic Non-invasive Ablation of Ventricular Tachycardia</brief_title>
  <official_title>STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Podlesi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Ostrava</source>
  <oversight_info>
    <has_dmc>No</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>
      STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart&#xD;
      disease (STAR-VT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this project is to evaluate feasibility and safety/toxicity of elimination of&#xD;
      ventricular tachycardia (VT) associated with structural heart disease by noninvasive&#xD;
      strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after&#xD;
      failed catheter ablation. The arrhythmogenic substrate will be identified by imaging&#xD;
      techniques and functionally by electroanatomic mapping and pacing. The recipients of&#xD;
      stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic&#xD;
      VTs (one of the procedures will be performed in an expert center). The target volume for&#xD;
      stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the&#xD;
      substrate defined by a combination of imaging and functional methods with an export of the&#xD;
      merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints&#xD;
      will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or&#xD;
      appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or&#xD;
      time do development of radiation toxicity (both acute and late).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in the design of the study&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of sustained VT burden in three 3-month intervals</measure>
    <time_frame>50 months</time_frame>
    <description>Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold</measure>
    <time_frame>50 months</time_frame>
    <description>All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3. Rate of acute (&lt;3 months) and late radiation-induced events according to CTCAE 4.0.</measure>
    <time_frame>53 months</time_frame>
    <description>The rate of acute (&lt;3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint of all-cause death and appropriate ICD shock</measure>
    <time_frame>50 months</time_frame>
    <description>The composite endpoint of all-cause death and appropriate ICD shock will be observed for the period of up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electric storm recurrence</measure>
    <time_frame>53 months</time_frame>
    <description>The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular hospitalisations</measure>
    <time_frame>53 months</time_frame>
    <description>The hospitalisations due to cardiovascular indications will be observed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>53 months</time_frame>
    <description>Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>4-D navigated stereotactic radiosurgical ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>4-D navigated stereotactic radio surgical ablation</intervention_name>
    <description>4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias</description>
    <arm_group_label>4-D navigated stereotactic radiosurgical ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy,&#xD;
             previous surgery for congenital heart disease)&#xD;
&#xD;
          -  Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)&#xD;
&#xD;
          -  Prior ≥1 catheter ablation procedure for monomorphic VT&#xD;
&#xD;
          -  VT recurrence early (&lt;12 months) after the last ablation with at least 2 episodes of&#xD;
             recurrent VT, including 1 episode while on amiodarone (if not contraindicated)&#xD;
&#xD;
          -  Age ≥30 years&#xD;
&#xD;
          -  Signed an IRB-approved (Institutional Review Board) written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or&#xD;
             cardiac surgery (&lt;3 months)&#xD;
&#xD;
          -  Primary electrical disease (channelopathy)&#xD;
&#xD;
          -  Reversible cause of VT (e.g. drug-induced, intoxications, etc)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Chronic heart failure New York Heart Association (NYHA) Class IV&#xD;
&#xD;
          -  Serious comorbidities with presumed life expectancy less than one year&#xD;
&#xD;
          -  Significant peripheral artery disease precluding retrograde aortic mapping&#xD;
&#xD;
          -  History of chest radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jakub Cvek, Ass.Prof.,MD,Ing.,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Clinical and Experimental Medicine Prague</name>
      <address>
        <city>Prague</city>
        <state>Central Bohemia</state>
        <zip>14021</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava-Poruba</city>
        <state>Czech Republic</state>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Podlesí</name>
      <address>
        <city>Třinec</city>
        <state>Moravian-Silesian Region</state>
        <zip>73961</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, Greene HL, Boczor S, Domanski M, Follmann D, Gent M, Roberts RS. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study. Eur Heart J. 2000 Dec;21(24):2071-8. doi: 10.1053/euhj.2000.2476.</citation>
    <PMID>11102258</PMID>
  </reference>
  <reference>
    <citation>Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.</citation>
    <PMID>11907286</PMID>
  </reference>
  <reference>
    <citation>Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.</citation>
    <PMID>16403928</PMID>
  </reference>
  <reference>
    <citation>Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.</citation>
    <PMID>23131066</PMID>
  </reference>
  <reference>
    <citation>Mallidi J, Nadkarni GN, Berger RD, Calkins H, Nazarian S. Meta-analysis of catheter ablation as an adjunct to medical therapy for treatment of ventricular tachycardia in patients with structural heart disease. Heart Rhythm. 2011 Apr;8(4):503-10. doi: 10.1016/j.hrthm.2010.12.015. Epub 2010 Dec 13.</citation>
    <PMID>21147263</PMID>
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    <citation>Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.</citation>
    <PMID>27149033</PMID>
  </reference>
  <reference>
    <citation>Aldhoon B, Wichterle D, Peichl P, Cihak R, Kautzner J. Outcomes of ventricular tachycardia ablation in patients with structural heart disease: The impact of electrical storm. PLoS One. 2017 Feb 10;12(2):e0171830. doi: 10.1371/journal.pone.0171830. eCollection 2017.</citation>
    <PMID>28187168</PMID>
  </reference>
  <reference>
    <citation>Raymond JM, Sacher F, Winslow R, Tedrow U, Stevenson WG. Catheter ablation for scar-related ventricular tachycardias. Curr Probl Cardiol. 2009 May;34(5):225-70. doi: 10.1016/j.cpcardiol.2009.01.002.</citation>
    <PMID>19348944</PMID>
  </reference>
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    <citation>Kumar S, Baldinger SH, Romero J, Fujii A, Mahida SN, Tedrow UB, Stevenson WG. Substrate-Based Ablation Versus Ablation Guided by Activation and Entrainment Mapping for Ventricular Tachycardia: A Systematic Review and Meta-Analysis. J Cardiovasc Electrophysiol. 2016 Dec;27(12):1437-1447. doi: 10.1111/jce.13088. Epub 2016 Oct 6.</citation>
    <PMID>27574120</PMID>
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    <citation>Jais P, Maury P, Khairy P, Sacher F, Nault I, Komatsu Y, Hocini M, Forclaz A, Jadidi AS, Weerasooryia R, Shah A, Derval N, Cochet H, Knecht S, Miyazaki S, Linton N, Rivard L, Wright M, Wilton SB, Scherr D, Pascale P, Roten L, Pederson M, Bordachar P, Laurent F, Kim SJ, Ritter P, Clementy J, Haissaguerre M. Elimination of local abnormal ventricular activities: a new end point for substrate modification in patients with scar-related ventricular tachycardia. Circulation. 2012 May 8;125(18):2184-96. doi: 10.1161/CIRCULATIONAHA.111.043216. Epub 2012 Apr 4.</citation>
    <PMID>22492578</PMID>
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    <citation>Di Biase L, Santangeli P, Burkhardt DJ, Bai R, Mohanty P, Carbucicchio C, Dello Russo A, Casella M, Mohanty S, Pump A, Hongo R, Beheiry S, Pelargonio G, Santarelli P, Zucchetti M, Horton R, Sanchez JE, Elayi CS, Lakkireddy D, Tondo C, Natale A. Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2012 Jul 10;60(2):132-41. doi: 10.1016/j.jacc.2012.03.044.</citation>
    <PMID>22766340</PMID>
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    <citation>Tzou WS, Frankel DS, Hegeman T, Supple GE, Garcia FC, Santangeli P, Katz DF, Sauer WH, Marchlinski FE. Core isolation of critical arrhythmia elements for treatment of multiple scar-based ventricular tachycardias. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):353-61. doi: 10.1161/CIRCEP.114.002310. Epub 2015 Feb 13.</citation>
    <PMID>25681389</PMID>
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    <citation>Tung R, Michowitz Y, Yu R, Mathuria N, Vaseghi M, Buch E, Bradfield J, Fujimura O, Gima J, Discepolo W, Mandapati R, Shivkumar K. Epicardial ablation of ventricular tachycardia: an institutional experience of safety and efficacy. Heart Rhythm. 2013 Apr;10(4):490-8. doi: 10.1016/j.hrthm.2012.12.013. Epub 2012 Dec 11.</citation>
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    <PMID>23727700</PMID>
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    <citation>Chang SD, Main W, Martin DP, Gibbs IC, Heilbrun MP. An analysis of the accuracy of the CyberKnife: a robotic frameless stereotactic radiosurgical system. Neurosurgery. 2003 Jan;52(1):140-6; discussion 146-7. doi: 10.1097/00006123-200301000-00018.</citation>
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    <PMID>29753550</PMID>
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    <citation>Regis J, Tuleasca C, Resseguier N, Carron R, Donnet A, Gaudart J, Levivier M. Long-term safety and efficacy of Gamma Knife surgery in classical trigeminal neuralgia: a 497-patient historical cohort study. J Neurosurg. 2016 Apr;124(4):1079-87. doi: 10.3171/2015.2.JNS142144. Epub 2015 Sep 4.</citation>
    <PMID>26339857</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Structural Heart Disease</keyword>
  <keyword>Ventricular Tachycardia</keyword>
  <keyword>Substrate Ablation</keyword>
  <keyword>Stereotactic Radiosurgery</keyword>
  <keyword>Functional Radiosurgery</keyword>
  <keyword>4D navigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The investigators have not decided to share the individual participant data with other researchers.</ipd_description>
  </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/NCT03819504
org study id: STAR-VT
secondary id: NV19-02-00212
nct id: NCT03819504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart
      disease (STAR-VT).
The goal of this project is to evaluate feasibility and safety/toxicity of elimination of
      ventricular tachycardia (VT) associated with structural heart disease by noninvasive
      strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after
      failed catheter ablation. The arrhythmogenic substrate will be identified by imaging
      techniques and functionally by electroanatomic mapping and pacing. The recipients of
      stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic
      VTs (one of the procedures will be performed in an expert center). The target volume for
      stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the
      substrate defined by a combination of imaging and functional methods with an export of the
      merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints
      will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or
      appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or
      time do development of radiation toxicity (both acute and late).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of sustained VT burden in three 3-month intervals
time frame: 50 months
description: Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
measure: Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold
time frame: 50 months
description: All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
measure: 3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.
time frame: 53 months
description: The rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
measure: Composite endpoint of all-cause death and appropriate ICD shock
time frame: 50 months
description: The composite endpoint of all-cause death and appropriate ICD shock will be observed for the period of up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
measure: Electric storm recurrence
time frame: 53 months
description: The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
measure: Cardiovascular hospitalisations
time frame: 53 months
description: The hospitalisations due to cardiovascular indications will be observed.
measure: Change in quality of life
time frame: 53 months
description: Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
arm group label: 4-D navigated stereotactic radiosurgical ablation
arm group type: Experimental
description: Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation
intervention type: Procedure
intervention name: 4-D navigated stereotactic radio surgical ablation
description: 4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias
arm group label: 4-D navigated stereotactic radiosurgical ablation
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Jakub Cvek, Ass.Prof.,MD,Ing.,PhD
role: Study Chair
affiliation: University Hospital Ostrava
facility: 
facility: 
facility: 
country: Czechia
citation: Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, Greene HL, Boczor S, Domanski M, Follmann D, Gent M, Roberts RS. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study. Eur Heart J. 2000 Dec;21(24):2071-8. doi: 10.1053/euhj.2000.2476.
PMID: 11102258
citation: Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
PMID: 11907286
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responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
sharing ipd: Undecided
ipd description: The investigators have not decided to share the individual participant data with other researchers.