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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Ablation of paroxysmal atrial fibrillation
Hartcentrum OLV Aalst
Aalst, Belgium
Hartcentrum Hasselt Jessa Ziekenhuis
Hasselt, Belgium
Nemocnice Na Homolce
Prague, Czechia
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
Time frame: 12 months post procedure
Acute procedure success
Confirmation of electrical isolation with a circular mapping catheter
Time frame: 30 minutes post procedure
Procedure and fluoroscopy time
Time will be taken
Time frame: During procedure
Incidence of peri-procedural complications
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
Time frame: From procedure to 12 months post procedure
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
Time frame: 12 months post procedure
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Universitätsklinik Erlangen
Erlangen, Bavaria, Germany
Isar Herz Zentrum
München, Bavaria, Germany
St. Vinzenz Hospital Köln
Cologne, North Rhine-Westphalia, Germany
UKSH, Universitäres Herzzentrum
Lübeck, Schleswig-Holstein, Germany
Vivantes Klinikum Am Urban
Berlin, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, Germany
...and 1 more locations