Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT Number: NCT06495216
Acronym: ZephIRE
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation
Interventions: DEVICE: Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator
Sponsor: Biosense Webster, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-17
Completion Date: 2025-12-26
Locations: Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, 3500, Belgium|UZ Brussel, Jette, 1090, Belgium

Summary:
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Primary Outcome Measures: Percentage of Participants with Primary Adverse Events (PAEs), Percentage of participants with PAEs will be reported. PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, severe pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis., Up to 3 months post-procedure|Percentage of Participants with Acute Effectiveness, Percentage of participants with acute effectiveness will be reported. Acute effectiveness is an electrical isolation of clinically relevant targeted pulmonary veins (PVs) which is evidenced by confirmation of entrance block, after adenosine/isoproterenol challenge, at the end of the index ablation procedure., Up to 3 months post-procedure
Secondary Outcome Measures: Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes During the Effectiveness Evaluation Period, Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT or AFL of unknown origin) episodes based on electrocardiographic data (more than equal to \[\>=\]30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91 to Day 365) on or off antiarrhythmic therapy will be reported. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12-month effectiveness failure., Within Day 91 to Day 365|Percentage of PVs that are Targeted in the Index Ablation Procedure with Sustained Isolation at Day 75, Percentage of PVs that are targeted in the index ablation procedure with sustained isolation, which is evidenced by electrical confirmation (through pacing for entrance block) of isolation at Day 75 post index ablation procedure will be reported., Day 75