Clinical trials: Pulmonary Vein Isolation
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
Atrial Fibrillation
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- NCT01824394
- Testing
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Volunteers
- 481 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in…
- Trial name
- NCT07106970
- Testing
- Linear ablation, PVI alone
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial…
- Trial name
- GreatPFA (NCT07511166)
- Volunteers
- 300 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Atrial Fibrillation (AF)
Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults.
- Trial name
- IMPRoVED-AF (NCT06935591)
- Testing
- Pulmonary Vein Isolation, vMap® + Pulmonary Vein Isolation
- Where
- 13 sites in United States, Germany
- Volunteers
- 423 people
- Sponsor
- Vektor Medical
Atrial Fibrillation
Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)
Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient…
- Trial name
- NCT02433613
- Where
- 41 sites in France, Georgia and 12 more
- Volunteers
- 1,071 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
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Trial name
- Q-FFICIENCY (NCT03775512)
- Testing
- RF Ablation with QDOT Micro
- Where
- 22 sites in United States
- Volunteers
- 283 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients.
- Trial name
- SUPIR (NCT01645917)
- Testing
- Arctic Front Advance Cardiac CryoAblation system
- Where
- Czechia
- Volunteers
- 21 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Paroxysmal Atrial Fibrillation
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of…
- Trial name
- HeartLight (NCT01456000)
- Testing
- EAS-AC (HeartLight), Control Arm Ablation
- Where
- 21 sites in United States
- Volunteers
- 405 people
- Sponsor
- CardioFocus
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
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
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic…
- Trial name
- NCT01803438
- Testing
- cryoballoon ablation system, Antiarrhythmic Drugs
- Where
- 19 sites in Argentina, Australia and 7 more
- Volunteers
- 220 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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.
Persistent Atrial Fibrillation, Heart Failure
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D…
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Trial name
- AMICA (NCT00652522)
- Testing
- ICD/CRT implant, AF ablation, Best Medical Treatment
- Where
- 16 sites in Germany, Hungary and 1 more
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an…
- Trial name
- aMAZE (NCT02513797)
- Testing
- LARIAT + PVI, Pulmonary Vein Isolation
- Where
- 53 sites in United States
- Volunteers
- 600 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation
The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat…
- Trial name
- SPAA PFA (NCT07527299)
- Testing
- VARIPULSE Catheter System, LAAO Device
- Where
- 11 sites in United States
- Volunteers
- 1,070 people
- Sponsor
- Biosense Webster, Inc.
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
Atrial Fibrillation
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe.
- Trial name
- NCT01767558
- Testing
- Ablation / MRI
- Where
- 11 sites in Belgium, France and 4 more
- Volunteers
- 56 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure