The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping \[stimulating and recording\] and, when used with a Generator, for cardiac ablation).
AZORG campus Aalst Moorselbaan
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Percentage of Participants With Primary Adverse Events (PAEs)
Percentage of participants with PAEs was reported. PAEs (within seven \[7\] days of the index ablation procedure) included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (up to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation (up to 30 days post-procedure), stroke/cerebrovascular accident (CVA), major vascular access complication, major bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Time frame: 90 days post catheter insertion on Day 0
Percentage of Participants With Acute Effectiveness Success
Percentage of participants with acute effectiveness success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PV; confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.
Time frame: Immediately post-procedure on Day 0 (post catheter insertion)
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure
Time frame: From Day 91 to Day 365 post catheter insertion on Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium
Montreal Heart Institute
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
KBC Split
Split, Croatia
IKEM
Prague, Czechia
Nemocnice na Homolce
Prague, Czechia
MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt a.M., Germany
...and 3 more locations