Clinical trials: Pulmonary Vein Isolation
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall…
- Trial name
- INSIDEPVs (NCT03372798)
- Testing
- ICE/IVUS imaging during atrial fibrillation ablation
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Oxford University Hospitals NHS Trust
Paroxysmal Atrial Fibrillation
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes.
- Trial name
- GANGLIA-AF (NCT02487654)
- Testing
- Pulmonary vein isolation, Ganglionated plexus ablation
- Where
- 3 sites in United Kingdom
- Volunteers
- 116 people
- Sponsor
- Imperial College London
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
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.
Atrial Fibrillation, Arrhythmia
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial ablation procedure.
- Conditions
- Atrial Fibrillation, Arrhythmia, Inflammation, Endothelial Dysfunction
- Trial name
- ATTAC (NCT00579098)
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Mayo Clinic
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University
Paroxysmal Atrial Fibrillation
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation.
- Trial name
- TOCCASTAR (NCT01278953)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
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.
Atrial Fibrillation Chronic, Persistent Atrial Fibrillation
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with…
- Trial name
- PIVoTAL (NCT03057548)
- Testing
- Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins, Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
- Where
- 2 sites in United States, Japan
- Volunteers
- 110 people
- Sponsor
- Arash Aryana, MD
Atrial Fibrillation, Persistent Common Pulmonary Vein
Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation
- Trial name
- APPLE (NCT01932112)
- Testing
- Adenosine arm
- Where
- South Korea
- Volunteers
- 378 people
- Sponsor
- Yong Seog Oh
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the…
- Trial name
- NCT01590875
- Testing
- Adenosine arm
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Atrial Fibrillation
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation
The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.
- Trial name
- NCT00408200
- Testing
- propafenone; flecainide; sotalol; dofetilide, Radiofrequency catheter ablation
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- University of Pennsylvania
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
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
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
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, Arrhythmia
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF).
- Trial name
- CABANA (NCT00911508)
- Testing
- Left atrial ablation, Rate or Rhythm Control Therapy
- Where
- 118 sites in United States, Australia and 8 more
- Volunteers
- 2,204 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation
Assessing Arrhythmias After Ablation Using Implantable Recorders
The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long…
- Trial name
- ABACUS (NCT01176617)
- Testing
- Reveal XT implantable loop recorder
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of Pennsylvania