Clinical trials: PFA
Atrial Arrhythmia, Atrial Fibrillation
VOLT-AF IDE Clinical Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06223789
- Testing
- Pulsed Field Ablation
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 392 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial…
- Trial name
- AVANT GUARD (NCT06096337)
- Testing
- FARAPULSE™ Pulsed Field Ablation (PFA) System, Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 484 people
- Sponsor
- Boston Scientific Corporation
Persistant Atrial Fibrillation
Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation
The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
- Trial name
- Quick AF (NCT07281521)
- Testing
- pulsed field ablation
- Where
- 3 sites in Croatia, Czechia
- Volunteers
- 200 people
- Sponsor
- CardioFocus
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
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…
- Trial name
- ZephIRE (NCT06495216)
- Testing
- Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system.
- Trial name
- REFINE-PFA (NCT07275151)
- Testing
- Pulmonary vein isolation ablation
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- CathVision ApS
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, 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
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and…
- Trial name
- SPECTRA-AF (NCT07788989)
- Testing
- VARIPULSE Catheter System (PVI), VARIPULSE Catheter System (PVI and PWI)
- Where
- United States
- Volunteers
- 2,300 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation (AF)
Measuring Local Potentials in PFA. MULTI PFA (EU)
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems.
- Trial name
- MULTI PFA (NCT07379697)
- Volunteers
- 30 people
- Sponsor
- CathVision ApS
Atrial Fibrillation
Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
- Trial name
- PARALELL (NCT05408754)
- Testing
- Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.
- Where
- 6 sites in Belgium, Canada and 4 more
- Volunteers
- 89 people
- Sponsor
- Adagio Medical
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
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
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 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.
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
Prostate Cancer
A Prospective, Single-Arm, Pilot Study of the ALPFA BPH PFA System in Men With Low, Intermediate and High-Risk Prostate Cancer
The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer.
- Trial name
- NCT07492381
- Testing
- ALPFA BPH PFA System
- Volunteers
- 50 people
- Sponsor
- ALPFA Medical
Ventricular Tachycardia
Evaluation of the DuoVT PFA System for Ventricular Tachycardia
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
- Trial name
- EXACT-VT (NCT07706712)
- Testing
- Ablation procedure with DuoVT PFA system
- Where
- 5 sites in Croatia, Czechia and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Atrial Arrhythmia, Atrial Fibrillation
AcQForce Pulsed Field Ablation-CE
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
- Trial name
- PFA-AF (NCT05113056)
- Testing
- Acutus Medical Pulsed Field Ablation System
- Where
- Czechia
- Volunteers
- 24 people
- Sponsor
- Acutus Medical
Atrial Fibrillation
PulseSelect™ PFA Global Registry
The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.
- Trial name
- NCT06393920
- Where
- 43 sites in Australia, Belgium and 14 more
- Volunteers
- 1,950 people
- Sponsor
- Medtronic Cardiac Ablation Solutions