Clinical trials: Pulsed Field Ablation
Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for…
- Trial name
- PULSED AF (NCT04198701)
- Testing
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 421 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- inspIRE (NCT04524364)
- Testing
- Pulsed Field Ablation (PFA) Therapy
- Where
- 13 sites in Austria, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
A RWS of the FARAPULSE in A Chinese Population With PAF
The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent…
- Trial name
- NCT05493852
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation…
- Trial name
- ADVANTAGE AF (NCT05443594)
- Testing
- Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 669 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF…
- Trial name
- CS1543 (NCT05272852)
- Testing
- FARAPULSE™ Pulsed Field Ablation System Plus
- Where
- 2 sites in Czechia
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation