Clinical trials: Pulmonary Vein Isolation
Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.
- Trial name
- Cryo-InitialAF (NCT04942834)
- Testing
- Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone, cryoballoon ablation
- Where
- 17 sites in China
- Volunteers
- 320 people
- Sponsor
- Ruijin Hospital
Atrial Fibrillation
Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor
The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein…
- Trial name
- RACE-AF (NCT03805555)
- Testing
- Radiofrequency ablation, Cryoballoon ablation
- Where
- Denmark
- Volunteers
- 105 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
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.
Paroxysmal Atrial Fibrillation
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation, and it can reduce the procedure time compared to conventional radiofrequency (RF) catheter ablation.
- Trial name
- NCT03920917
- Testing
- Cryoballoon Pulmonary Vein isolation, Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
- Where
- South Korea
- Volunteers
- 330 people
- Sponsor
- Yonsei University
Atrial Fibrillation (AF)
Safety and Efficacy of Pulmonary Vein Isolation Using Pulsed-field Ablation (PFA) Combined with Either PFA-based Left Atrial Posterior Wall Isolation or Vein of Marshall Ethanol Ablation in Patients with Persistent Atrial Fibrillation
This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.
- Trial name
- SAVIOR (NCT06878924)
- Volunteers
- 162 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Atrial Fibrillation, Persistent Atrial Fibrillation
CatHeter Ablation of perSistEnd Atrial Fibrillation: Pulmonary Vein Isolation Versus Defragmentation. The CHASE-AF Study
Study design: Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein isolation, biatrial…
- Trial name
- CHASE-AF (NCT01580124)
- Testing
- PVI alone, PVI + Defragmentation + linear lesions
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT)…
- Trial name
- REDUCE AF (NCT01710150)
- Testing
- CTI ablation alone, CTI ablation and Pulmonary vein isolation (PVI)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Atrial Fibrillation, Atrial Fibrillation, Persistent
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm
The aim of this study is to evaluate benefits of electric cardioversion in the early and long-term postoperative period in patients after radiofrequency catheter isolation of pulmonary veins.
- Trial name
- NCT06654401
- Testing
- Transthoracic echocardiography, 24-hour ECG Monitor, Electroanatomic mapping
- Where
- Russia
- Volunteers
- 125 people
- Sponsor
- Saint Petersburg State University, Russia
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, Coronary Artery Disease
The Assessment of Progression of Paroxysmal AF After CABG
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
- Trial name
- NCT02246803
- Testing
- CABG+Pulmonary vein isolation procedure, Isolated CABG
- Where
- Russia
- Volunteers
- 72 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision Cube® System
The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05114382
- Testing
- EP Procedure
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 24 people
- Sponsor
- CathVision ApS
Paroxysmal Atrial Fibrillation
Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual…
- Trial name
- NCT03912324
- Testing
- Unipolar voltage subtraction map guided PV isolation group, CT myocardial thickness map guided PV isolation group, Empirical PV isolation group
- Where
- South Korea
- Volunteers
- 220 people
- Sponsor
- Yonsei University
Atrial Fibrillation, Pulmonary Vein Isolation
Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium
This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins.
- Conditions
- Atrial Fibrillation, Pulmonary Vein Isolation, Ablation Therapy
- Trial name
- PFALCO Remap (NCT05812261)
- Testing
- Creating an electro-anatomical map
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Onze Lieve Vrouwe Gasthuis
Atrial Fibrillation (AF), Esophageal Perforation
Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation: a Randomized Comparison of the 50W and 90W Power Settings
Pulmonary vein isolation (PVI) is the most effective means of maintaining sinus rhythm in atrial fibrillation (AF), while a widely used approach to PVI is point-by-point radiofrequency (RF) catheter ablation.
- Conditions
- Atrial Fibrillation (AF), Esophageal Perforation, Esophageal Perforation, Traumatic
- Trial name
- HPSD-Esophagus (NCT06617442)
- Testing
- Pulmonary vein isolation
- Where
- Hungary
- Volunteers
- 150 people
- Sponsor
- Semmelweis University
Atrial Fibrillation Chronic
Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have proven ineffective.
- Trial name
- OPTIMA (NCT04101539)
- Testing
- OPTIMA-guided catheter ablation, Standard PVI
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Johns Hopkins University
Atrial Fibrillation, Heart Failure, Systolic
Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)
In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon…
- Trial name
- AFICHE (NCT03573869)
- Testing
- Cryoballoon ablation
- Where
- Greece
- Volunteers
- 404 people
- Sponsor
- G.Gennimatas General Hospital
Atrial Fibrillation
Isolation of Pulmonary Veins With the Aid of Magnetic Resonance Imaging
The ALICIA-FA study will elucidate whether targeting atrial myocardial fibrosis identified by late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) improves atrial fibrillation (AF) ablation outcomes.
- Trial name
- ALICIA (NCT02698631)
- Testing
- Conventional AF ablation, LGE-MRI guided AF ablation
- Where
- 2 sites in Spain
- Volunteers
- 154 people
- Sponsor
- Hospital Clinic of Barcelona
Atrial Fibrillation (AF)
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Atrial fibrillation (AF) is a common heart rhythm disorder associated with stroke, heart failure, and increased mortality. Catheter ablation with pulmonary vein isolation (PVI) is an effective rhythm-control strategy, but 20-30%…
- Trial name
- FINE-CA (NCT07799519)
- Testing
- Finerenone
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- National Cheng-Kung University Hospital
Atrial Fibrillation
Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF
Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate.
- Trial name
- NCT02492256
- Testing
- Pulmonary vein isolation, GP ablation guided by SUMO technology, ILR implantation
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Atrial Fibrillation
Release of Acetylcholine From the Ganglionated Plexus During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)
Determine whether the presence of acetylcholine in the systemic circulation, correlates with the hypotensive response observed during the thaw phase of cryoballoon ablation.
- Trial name
- NCT03636100
- Testing
- Cryoballoon ablation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Saint Luke's Health System