Clinical trials: Pulmonary Vein Ablation
Paroxysmal Atrial Fibrillation
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The Genesis Feasibility Study will collect clinical information on the use of the Bard Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the…
- Trial name
- GENESIS (NCT01430949)
- Testing
- Catheter Ablation of Paroxysmal Atrial Fibrillation
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- C. R. Bard
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.
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
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
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
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Atrial Fibrillation
Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.
DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI)…
- Trial name
- DISPLAY-AF (NCT07807423)
- Testing
- Complete biatrial mapping
- Where
- 5 sites in France
- Volunteers
- 125 people
- Sponsor
- Volta Medical
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
High Intensity Focused Ultrasound (HIFU) Ablation System Study
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic…
- Trial name
- NCT00392106
- Testing
- propafenone, flecainide, dofetilide
- Where
- 21 sites in United States, Czechia
- Volunteers
- 240 people
- Sponsor
- ProRhythm, Inc.
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.
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
Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Paroxysmal Atrial Fibrillation
Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death.
- Trial name
- NCT02614521
- Testing
- pulmonary veins ablation's successful outcome
- Where
- Greece
- Sponsor
- Elpen Pharmaceutical Co. Inc.
Atrial Fibrillation
Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.
- Trial name
- NCT00982475
- Testing
- Pulmonary vein isolation with radiofrequency current
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- Dr. Kai Jaquet
Atrial Fibrillation, Atrial Flutter
Feasibility Study for Optically Guided Radiofrequency Ablation Catheter
Clinical study intended to evaluate the feasibility of a new irrigated RF ablation catheter that allows the physiologist to perform a regular RF ablation procedure while it is being monitored through an imaging technique known as…
- Trial name
- NEOVIEW (NCT03589742)
- Testing
- AblaView® Ablation Catheter
- Where
- Czechia
- Volunteers
- 4 people
- Sponsor
- Medlumics
Atrial Fibrillation
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or…
- Trial name
- NCT00367757
- Testing
- Ablate AF triggers via PVI, Substrate via CFAEs, Combined approach for AF ablation
- Where
- 8 sites in Canada, Italy and 2 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
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
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
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