Clinical trials: FARAPULSE
Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
Application-Based Integrated Care in Patients After Pulse Field Ablation
"Atrial fibrillation (AF) is known as the most common sustained arrhythmia observed in clinical situation. Pulse Field Ablation (PFA) is a recently introduced, effective atrial fibrillation (AF) ablation modality.
- Trial name
- NCT07119528
- Testing
- AF application enhancing AF education, AF application without enhancing AF education and drug adhrence
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Yonsei University
Atrial Fibrillation (AF)
FARAPULSE Workflow Assessment Registry
The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field…
- Trial name
- FARAWAY (NCT06656884)
- Where
- 28 sites in Austria, Belgium and 8 more
- Volunteers
- 524 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (Paroxysmal)
A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava
This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for…
- Trial name
- NCT07162597
- Testing
- Pulsed Field Ablation
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
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 (AF)
The Added Value of Three-dimensional Electroanatomic Mapping For Accurate Delivery Of Pulsed Field Ablation In The Pulmonary Veins Compared To Pulsed Field Ablation With Fluoroscopy And/Or Intracardiac Echocardiography Alone In The Treatment Of Atrial Fibrillation: MAP-PFA Study
This is a randomized control trial that aims to evaluate the added value of electro-anatomical mapping to improve the quality of pulse field ablation lesions during Atrial fibrillation ablation.
- Trial name
- MAP-PFA (NCT07014423)
- Testing
- The Pulsed Field Ablation to Isolate the Pulmonary Vein with the utilization of FARAVIEW mapping software., The Pulsed Field Ablation to Isolate the Pulmonary Vein without the utilization of FARAVIEW mapping software.
- Where
- 2 sites in Netherlands
- Volunteers
- 32 people
- Sponsor
- University Medical Center Groningen
Paroxysmal Atrial Fibrillation
ADVENT Post Approval Study
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
- Trial name
- ADVENTPAS (NCT06431815)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 228 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Atrial Fibrillation Ablation
Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters
The FARAPULSE PFA catheter (Boston Scientific), a first-generation Pulsed Field Ablation (PFA) tool, has demonstrated good performance in isolating pulmonary veins (PV).
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Pulsed Field Ablation
- Trial name
- NCT07130773
- Testing
- Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT, FARAPULSE with pre-ablation CT
- Where
- Switzerland
- Volunteers
- 58 people
- Sponsor
- Cardiocentro Ticino
Atrial Fibrillation (AF), Pulsed-field Ablation
Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy
Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).
- Trial name
- Faraview Remap (NCT07752771)
- Testing
- catheter ablation
- Where
- Hungary
- Volunteers
- 20 people
- Sponsor
- Semmelweis University
Paroxysmal Atrial Fibrillation
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
- Trial name
- PEFCATII (NCT04170608)
- Testing
- FARAPULSE Endocardial Multi Ablation System
- Where
- 2 sites in Croatia, Czechia
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and…
- Trial name
- IMPULSE-EVO (NCT07444320)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System
- Where
- 4 sites in Croatia, Czechia and 2 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources)…
- Trial name
- OPTIMIZE (NCT07187115)
- Testing
- FARAPOINT Pulsed Field Ablation System, OptiMap System (non-ablative), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 699 people
- Sponsor
- Boston Scientific Corporation
PFA Ablation and LAAC Procedures
Concomitant LAAC/AF Ablation (Watchman FLX Pro)
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
- Trial name
- NCT07041125
- Testing
- Watchman FLX™ Pro device.
- Where
- 15 sites in United States
- Volunteers
- 122 people
- Sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
Paroxysmal Atrial Fibrillation
A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03714178
- Testing
- FARAPULSE Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 71 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
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 Cardiac Ablation System Plus is a…
- Trial name
- PersAFOne II (NCT05152966)
- Testing
- Ablation
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
- Trial name
- ReMATCH (NCT06735534)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 376 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
Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation
PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
- Trial name
- PersAFOne (NCT04170621)
- Testing
- Ablation
- Where
- 2 sites in Croatia, Czechia
- Volunteers
- 28 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
- Trial name
- FOLLOW-AF (NCT07471308)
- Testing
- AF Recurrence RIsk Assessment post pulmonary vein isolation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- CathVision ApS