Clinical trials: Pulsed Field Ablation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
- Trial name
- PULSAR (NCT05462145)
- Testing
- Globe Pulsed Field System
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 549 people
- Sponsor
- Kardium Inc.
Atrial Fibrillation Paroxysmal, Cardiac Ablation
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal…
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- Trial name
- NANOPULSE-AF (NCT07018596)
- Testing
- CellFX nsPFA Cardiac Catheter System
- Where
- Czechia
- Volunteers
- 215 people
- Sponsor
- Pulse Biosciences, Inc.
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
Atrial Fibrillation
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage…
- Trial name
- PULSE (NCT07621003)
- Testing
- Ablation of atrial fibrillation (AF)
- Where
- 10 sites in Germany
- Volunteers
- 264 people
- Sponsor
- Asklepios proresearch
Paroxysmal Atrial Fibrillation
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial…
- Trial name
- NCT05114954
- Testing
- CardioPulsesTM pulsed field ablation system
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 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
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
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
Atrial Fibrillation (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch
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
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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 Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
- Conditions
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- Trial name
- PSVT (NCT05820035)
- Testing
- Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Thyroid Nodule, Thyroid Goiter
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
The primary objective of this study is to reproduce in a multi-center study results obtained during the feasibility First-In-Human (FIH) study with Prof.
- Conditions
- Thyroid Nodule, Thyroid Goiter, Ablation
- Trial name
- PRECISE-BTN (NCT07287176)
- Testing
- nPulse Vybrance Percutaneous Electrode System
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Pulse Biosciences, Inc.
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
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with…
- Trial name
- PERSIGMA RCT (NCT07523750)
- Testing
- VARIPULSE Catheter, FARAWAVE Catheter
- Where
- 10 sites in United States
- Volunteers
- 566 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
Local Potential Measurement In PFA: A Pilot Study
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the…
- Trial name
- NCT06877156
- Where
- Croatia
- Volunteers
- 9 people
- Sponsor
- CathVision ApS
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