Clinical trials: Pulsed Field Ablation
Atrial Fibrillation, Pulsed-field Ablation
Pulsed-field Ablation for Patients With Asymptomatic Non-paroxysmal Atrial Fibrillation
The goal of the study is to test the hypothesis whether the treatment of patients with asymptomatic non-paroxysmal AF based on catheter ablation will be superior than conservative approach consisting of electrical cardioversion…
- Conditions
- Atrial Fibrillation, Pulsed-field Ablation, Functional Exercise Testing
- Trial name
- NCT06166524
- Testing
- Catheter ablation for atrial fibrillation using pulsed-field energy, Conservative arm
- Where
- Czechia
- Volunteers
- 124 people
- Sponsor
- Charles University, Czech Republic
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.
Paroxysmal Atrial Fibrillation
FIH of PFBalloon for PVI
The goal of this clinical trial is to assess the safety and effectiveness of a conformal pulsed field ablation (PFA) balloon catheter for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF).
- Trial name
- NCT07320976
- Testing
- PVI with a novel PFA catheter
- Where
- China
- Volunteers
- 35 people
- Sponsor
- The Third People's Hospital of Chengdu
Persistent Atrial Fibrillation
PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation
This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field…
- Trial name
- NCT07321002
- Testing
- Ablation with the PFLotus catheter and Depolar system
- Volunteers
- 35 people
- Sponsor
- The Third People's Hospital of Chengdu
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
Atrial Fibrillation (Paroxysmal)
TWOSOME Trial: Single-Shot Versus Single-Tip Pulsed Field Ablation for Pulmonary Vein Isolation
Two non-thermal ablation techniques approved for routine clinical practice (CE-marked) for the interventional treatment of atrial fibrillation are compared in a 1:1 randomization to investigate patient data, procedural data…
- Trial name
- NCT07175727
- Testing
- Pulmonary vein isolation, cerebral magnetic resonance tomography, Biomarker assessment (C-reacitve Protein, troponine)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Alfried Krupp Krankenhaus
Colon Polyp
PULSed Field ablAtion of coloRectal Polyps
The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps.
- Trial name
- PULSAR (NCT06317727)
- Testing
- Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device)
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- King's College Hospital NHS Trust
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
Ventricular Tachyarrhythmia, Ventricular Arrythmia
Ventricular Catheter Ablation Study (VCAS)
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex…
- Conditions
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction
- Trial name
- VCAS (NCT06203262)
- Testing
- FieldForce™ Ablation System Ventricular Tachycardia, FieldForce™ Ablation System Premature Ventricular Contractions
- Where
- 2 sites in Czechia
- Volunteers
- 34 people
- Sponsor
- Field Medical
Ablation of Arrhythmia's
Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems
This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent…
- Trial name
- MICROPFA (NCT07610018)
- Testing
- Pulsed field ablation using PulseSelect system, Pulsed field ablation using Varipulse system, Pulsed field ablation using Farapulse system
- Where
- 2 sites in Croatia
- Volunteers
- 100 people
- Sponsor
- Ivan Zeljkovic
Atrial Fibrillation
Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF
This is a prospective, multicenter, randomized controlled trial comparing CT-guided versus empirical pulsed field ablation (PFA) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT07068646
- Testing
- CT myocardial thickness map guided PV isolation group, Empirical PV isolation group
- Where
- South Korea
- Volunteers
- 298 people
- Sponsor
- Yonsei University
Atrial Fibrillation
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD).
- Trial name
- DOPPIO (NCT07021313)
- Testing
- Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation, Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
- Where
- Netherlands
- Volunteers
- 378 people
- Sponsor
- R&D Cardiologie
Atrial Fibrillation
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years.
- Trial name
- SAFFICIENT (NCT06488820)
- Testing
- Catheter ablation using pulsed-field ablation (PFA) system
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Atril Fibrillation, Cardiac Arrhythmia
Pulsed ElectRic FiEld Versus Cryoballoon for PAF
This study has been designed to compare the success rate of two different commercially available ablation technologies, namely PFA and Cryo. Both technologies are standard of care ablation procedures.
- Conditions
- Atril Fibrillation, Cardiac Arrhythmia, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- PERFECT-PAF (NCT07100834)
- Testing
- Single-Shot Pulsed Field Ablation (FARAPULSE™ Pulsed Field Ablation System), Single-Shot Cryoballoon Devices (Arctic Front Advance PRO, Medtronic Inc., Minneapolis, MN, USA; POLARx and POLARx FIT Balloon Catheter, Marlborough, MA, USA)
- Where
- 6 sites in Belgium, Croatia and 3 more
- Volunteers
- 269 people
- Sponsor
- Universitair Ziekenhuis Brussel
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
Persistent Atrial Fibrillation
FIH Study of PFLotus in Persistent Atrial Fibrillation
Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation.
- Trial name
- PFLotus- FIH (NCT07301190)
- Testing
- Pulse field ablation with the PFLotus catheter
- Where
- China
- Volunteers
- 40 people
- Sponsor
- The Third People's Hospital of Chengdu
Atrial Fibrillation (AF)
LA Function After PFA in Paroxysmal AF
A prospective study that investigates the changes in LA echocardiographic parameters after PFA for paroxysmal AF.
- Trial name
- NCT07439016
- Testing
- LA and LAA function measurements
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- Charles University, Czech Republic
Atrial Fibrillation
Pulsed-field Ablation Vs. Sham Ablation to Treat AF
The study is planned as a single-blind, multicenter, prospective, randomized study. Sixty sbjects will be randomized 1:1 to either: (i) EP study + PFA, or (ii) EP study + Sham ablation control.
- Trial name
- NCT05717725
- Testing
- Pulsed-field ablation
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic
Atrial Fibrillation
Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months…
- Trial name
- PULSED-ICE-CMR (NCT06220006)
- Testing
- Pulmonary vein isolation
- Where
- Spain
- Volunteers
- 104 people
- Sponsor
- Hospital Clinic of Barcelona