Clinical trials: Pulmonary Vein Ablation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial…
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- ReDEFINE-AF (NCT07820930)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation System
- Volunteers
- 650 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Atrial Fibrillation
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early…
- Trial name
- NCT02213731
- Testing
- Holter monitoring
- Where
- 14 sites in France, Germany and 1 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Arrhythmias, Cardiac, Paroxysmal Atrial Fibrillation
InsightPFA Trial of the LotosPFA Catheter
This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.
- Trial name
- InsightPFA (NCT06014996)
- Testing
- Pulsed Field Ablation (PFA) Therapy, Radiofrequency Ablation（RAF）Therapy
- Where
- 10 sites in China
- Volunteers
- 292 people
- Sponsor
- Insight Medtech Co., Ltd.
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
Atrial Fibrillation, Tachycardia
Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation
The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as…
- Trial name
- Alster-Lost (NCT00820625)
- Testing
- pulmonary vein isolation, pulmonary vein isolation with additional ablation of fragmented potentials
- Where
- Germany
- Volunteers
- 124 people
- Sponsor
- Asklepios proresearch
Atrial Fibrillation
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF)…
- Trial name
- NCT02348723
- Testing
- Warfarin, Dabigatran Etexilate 150mg
- Where
- 87 sites in United States, Belgium and 9 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Paroxysmal Atrial Fibrillation
Evaluation of Ablation Index and VISITAG™ (ABI-173)
The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or…
- Trial name
- VISTAX (NCT03062046)
- Testing
- RF ablation
- Where
- 17 sites in Austria, Belgium and 7 more
- Volunteers
- 340 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of…
- Trial name
- GLOBAL-PF (NCT06973031)
- Testing
- Globe Pulsed Field System
- Where
- Germany
- Volunteers
- 115 people
- Sponsor
- Kardium Inc.
Paroxysmal Atrial Fibrillation
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial…
- Trial name
- FIRMAP-AF (NCT02703454)
- Testing
- FIRM-guided RF ablation, Conventional RF ablation
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized…
- Trial name
- ERACE (NCT01520532)
- Testing
- Magnetic Resonance Imaging (MRI)
- Where
- 7 sites in Belgium, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Atrial Fibrillation
Pulmonary Vein Ablation Versus Amiodarone in the Elderly
The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with…
- Trial name
- PAVANE (NCT01276093)
- Testing
- PVI ablation, Amiodarone
- Where
- 6 sites in Netherlands
- Volunteers
- 59 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Ablation of the Pulmonary Veins for Paroxysmal Afib
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)
- Trial name
- MAP-PAF (NCT00744874)
- Testing
- RF Ablation procedure
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 55 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
SMART China, A Multi-center Clinical Registry Study
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Trial name
- NCT02485925
- Testing
- THERMOCOOL® SMARTTOUCH™
- Volunteers
- 200 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation
- Trial name
- En-GARDE (NCT01057394)
- Testing
- Endoscopically guided PVI Ablation, RF PVI Ablation
- Where
- 2 sites in Czechia, Italy
- Volunteers
- 21 people
- Sponsor
- CardioFocus
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 (Paroxysmal)
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF).
- Trial name
- VISION AF (NCT06828939)
- Testing
- pulsed field ablation
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- CardioFocus