CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: Ablation catheter
- Registration Number
- NCT03056222
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HeartLight® EGLA Ablation catheter Participants will be treated with the endoscopically guided laser ablation catheter Contact Force Sensing Irrigated RF ablation Ablation catheter Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
- Primary Outcome Measures
Name Time Method Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs 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
Name Time Method Incidence of peri-procedural complications 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
Acute procedure success 30 minutes post procedure Confirmation of electrical isolation with a circular mapping catheter
Procedure and fluoroscopy time During procedure Time will be taken
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs 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
Trial Locations
- Locations (11)
Hartcentrum OLV Aalst
🇧🇪Aalst, Belgium
St. Vinzenz Hospital Köln
🇩🇪Köln, NRW, Germany
Universitätsklinik Erlangen
🇩🇪Erlangen, Bavaria, Germany
Isar Herz Zentrum
🇩🇪München, Bavaria, Germany
Hartcentrum Hasselt Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Nemocnice Na Homolce
🇨🇿Prague, Czechia
UKSH, Universitäres Herzzentrum
🇩🇪Lübeck, Schleswig-Holstein, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
🇩🇪Hamburg, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom