Clinical trials: FARAPULSE
Atrial Fibrillation, Pulsed Field Ablation
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field…
- Conditions
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- Trial name
- OPALISE (NCT06808217)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 22 sites in Austria, France and 8 more
- Volunteers
- 550 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 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
Atrial Fibrillation
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.
- Trial name
- FARADISE (NCT05501873)
- Testing
- FARAPULSE Pulsed Field Ablation system
- Where
- 48 sites in Australia, Austria and 19 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 5 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial…
- Trial name
- DISRUPT-AF (NCT06335082)
- Testing
- Pulsed Field Ablation
- Where
- 36 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC