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CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)

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ClinicalTrials.gov Identifier: NCT03056222
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
I-Med-Pro GmbH

Brief Summary:
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Ablation catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HeartLight® EGLA
Participants will be treated with the endoscopically guided laser ablation catheter
Device: Ablation catheter
Ablation of paroxysmal atrial fibrillation

Active Comparator: Contact Force Sensing Irrigated RF ablation
Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
Device: Ablation catheter
Ablation of paroxysmal atrial fibrillation




Primary Outcome Measures :
  1. Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs [ Time Frame: 12 months post procedure ]
    Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure


Secondary Outcome Measures :
  1. Acute procedure success [ Time Frame: 30 minutes post procedure ]
    Confirmation of electrical isolation with a circular mapping catheter

  2. Procedure and fluoroscopy time [ Time Frame: During procedure ]
    Time will be taken

  3. Incidence of peri-procedural complications [ Time Frame: From procedure to 12 months post procedure ]
    E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death

  4. Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs [ Time Frame: 12 months post procedure ]
    Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must not have undergone a previous ablation for the treatment of PAF
  • AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours

Exclusion Criteria:

  • Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
  • Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
  • More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
  • Documented left atrial thrombus on imaging
  • Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
  • New York Heart Association (NYHA) functional Class III or Class IV heart failure
  • Left ventricular ejection fraction < 30%
  • Left atrial size > 55 mm as measured in the parasternal antero-posterior view
  • Myocardial infarction within 60 days prior to enrolment
  • Woman of childbearing potential who is pregnant, lactating or not using adequate birth control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056222


Contacts
Contact: Doris Wächter, Dr +49 171 3767676 waechter@imedpro.de
Contact: Knut M Scharnberger, Dipl.Phys. +49 171 3766666 scharnberger@imedpro.de

Locations
Belgium
Hartcentrum OLV Aalst Recruiting
Aalst, Belgium, 9300
Contact: Tom De Potter, Dr.    +3253724433    tom.de.potter@olvz-aalst.be   
Hartcentrum Hasselt Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Pieter Koopman, Dr.    +3211373565    pieter.koopman@jessazh.be   
Contact: johan vijgen, Dr.    +3211307842    johan.vijgen@jessazh.be   
Czechia
Nemocnice Na Homolce Recruiting
Prague, Czechia, 15030
Contact: Petr Neuzil, Prof    +420 257 272 211    petr.neuzil@homolka.cz   
Germany
Universitätsklinik Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Martin Arnold, Dr. med.    0+49 9131 8535000    martin.arnold@uk-erlangen.de   
Isar Herz Zentrum Recruiting
München, Bavaria, Germany, 80331
Contact: Turgut Brodherr, Dr. med.    +49 89 149903 ext 6000    Turgut.Brodherr@isarklinikum.de   
St. Vinzenz Hospital Köln Recruiting
Köln, NRW, Germany, 50733
Contact: Wolfgang Fehske, PD Dr.    +49 221 7712 ext 351    wolfgang.fehske@cellitinnen.de   
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Contact: Hüseyin Ince, Prof.Dr.    +49 30 13022 ext 5101    hueseyin.ince@vivantes.de   
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Andreas Metzner, PD Dr    +49 40 28902305    a.metzner@asklepios.com   
Sponsors and Collaborators
I-Med-Pro GmbH
Investigators
Principal Investigator: Andreas Metzner, PD Dr Asklepios Klinik St. Georg, Hamburg, Germany

Responsible Party: I-Med-Pro GmbH
ClinicalTrials.gov Identifier: NCT03056222     History of Changes
Other Study ID Numbers: CF2 Rev.1 IMP
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes