<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/NCT03246594</url>
  </required_header>
  <id_info>
    <org_study_id>Opera-2016</org_study_id>
    <nct_id>NCT03246594</nct_id>
  </id_info>
  <brief_title>Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation</brief_title>
  <acronym>OPERA</acronym>
  <official_title>Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart Center Leipzig - University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart Center Leipzig - University Hospital</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>
      The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation&#xD;
      of atrial fibrillation regarding oesophageal ulcers after ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial&#xD;
      fibrillation regarding oesophageal complications after ablation.&#xD;
&#xD;
      200 patients will be prospectively randomised into 2 groups. The conventional group will&#xD;
      undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the&#xD;
      temperature during ablation.&#xD;
&#xD;
      In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior&#xD;
      left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for&#xD;
      evaluation of oesophageal complications the day after the procedure.&#xD;
&#xD;
      All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for&#xD;
      complications (primary endpoint) and rhythm stability. (secondary endpoint)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">October 24, 2019</completion_date>
  <primary_completion_date type="Actual">April 25, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oesophageal complications after RF Ablation depending on using an oesophageal probe</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Incidence of oesophageal mucosa alterations in gastroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rhythm stability after RF ablation of atrial fibrillation (AF)</measure>
    <time_frame>6 Months</time_frame>
    <description>Percentage of AF/AT recurrences in 7 day holter at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Esophageal Probe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive ablation for atrial fibrillation with a oesophageal probe placed for temperature monitoring.&#xD;
Placement of oesophageal probe for temperature measurement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Esophageal Probe</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring.&#xD;
Intervention: Power limitation of RF generator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of oesophageal probe for temperature measurement</intervention_name>
    <description>The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus</description>
    <arm_group_label>Esophageal Probe</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Power limitation of RF generator</intervention_name>
    <description>no probe utilized; Limit the RF Generator Output to 25W</description>
    <arm_group_label>No Esophageal Probe</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 lead ECG with documented atrial fibrillation&#xD;
&#xD;
          -  Indication for RF ablation of atrial fibrillation according to the recent guidelines&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Age 18-85 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or possible pregnancy without negative test within 48h prior to ablation&#xD;
&#xD;
          -  Intracardiac thrombus&#xD;
&#xD;
          -  Contraindication for oral anticoagulation&#xD;
&#xD;
          -  Conditions, that may complicate the positioning of the oesophageal probe&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heart Center Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>esophageal probe</keyword>
  <keyword>thermolesion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03246594
org study id: Opera-2016
nct id: NCT03246594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation
      of atrial fibrillation regarding oesophageal ulcers after ablation.
The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial
      fibrillation regarding oesophageal complications after ablation.

      200 patients will be prospectively randomised into 2 groups. The conventional group will
      undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the
      temperature during ablation.

      In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior
      left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for
      evaluation of oesophageal complications the day after the procedure.

      All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for
      complications (primary endpoint) and rhythm stability. (secondary endpoint)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Oesophageal complications after RF Ablation depending on using an oesophageal probe
time frame: Up to 6 months
description: Incidence of oesophageal mucosa alterations in gastroscopy
measure: Rhythm stability after RF ablation of atrial fibrillation (AF)
time frame: 6 Months
description: Percentage of AF/AT recurrences in 7 day holter at 6 months
arm group label: Esophageal Probe
arm group type: Experimental
description: Participants in this group will receive ablation for atrial fibrillation with a oesophageal probe placed for temperature monitoring.
Placement of oesophageal probe for temperature measurement
arm group label: No Esophageal Probe
arm group type: Experimental
description: Participants in this group will receive ablation for atrial fibrillation without a oesophageal probe placed for temperature monitoring.
Intervention: Power limitation of RF generator
intervention type: Device
intervention name: Placement of oesophageal probe for temperature measurement
description: The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
arm group label: Esophageal Probe
intervention type: Device
intervention name: Power limitation of RF generator
description: no probe utilized; Limit the RF Generator Output to 25W
arm group label: No Esophageal Probe
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation