Randomized Trial: High Power Short Duration Versus Ablation Index

Status Recruiting

Clinical Trial Summary

The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90 %. This prospective, randomized study investigated the efficacy of pulmonary vein isolation with RF-energy following the CLOSE protocol with standard energy application (30 Watts) versus PVI with RF-energy with high power settings (45 Watts).

Clinical Trial Description

A total number of 176 patients undergoing de-novo catheter ablation for paroxysmal AF are planned to be randomized to two different treatment arms. In group-A patients, PVI was performed with RF-energy with standard power settings of 30 Watts in a temperature-controlled mode. The ablation procedure in group B was performed with RF-energy with higher power settings of 45 Watts. In both groups the ablation is performed with ablation index (AI) and following the CLOSE protocol (AI and ≤ 6 mm interlesion distance using a surround flow catheter, Biosense Webster Thermocool STSF). A total of 88 patients are planned to be randomized into each group, the follow-up period will be 12 months after the first procedure. The primary endpoint is freedom of all atrial arrhythmias after one procedure. The secondary endpoint is procedural time. The third endpoint is safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05251545
Study type	Interventional
Source	Robert Bosch Medical Center
Contact	Peter Ong, Prof
Phone	004971181010
Email	peter.ong@rbk.de
Status	Recruiting
Phase	N/A
Start date	September 1, 2021
Completion date	September 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03593486` - Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation	N/A
Terminated	`NCT01546207` - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia	N/A
Active, not recruiting	`NCT06124690` - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas	N/A
Not yet recruiting	`NCT04780438` - Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.	Early Phase 1
Active, not recruiting	`NCT03695484` - Registry Evaluating AF Ablation Techniques
Recruiting	`NCT05777850` - High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter	N/A
Not yet recruiting	`NCT05565183` - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.	N/A
Recruiting	`NCT06160076` - Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation-2
Not yet recruiting	`NCT05575544` - Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation	N/A
Recruiting	`NCT04678258` - Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation	N/A
Active, not recruiting	`NCT01630031` - Contact Force Sensing and Pulmonary Vein Isolation	N/A
Completed	`NCT04896424` - Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation	N/A
Completed	`NCT04906720` - Post-Ablation Pericarditis Reduction Study	Phase 2
Not yet recruiting	`NCT05273645` - PrOgnosis Following Esophageal fisTula formaTion in Pts Undergoing cathetER Ablation for AF Study
Completed	`NCT03140631` - Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation	Phase 4
Active, not recruiting	`NCT03514693` - Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation	N/A
Recruiting	`NCT03832959` - Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.	N/A
Not yet recruiting	`NCT05716581` - Prognostic Factors for Ablation of Atrial Fibrillation
Active, not recruiting	`NCT04405258` - Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial	Phase 4
Completed	`NCT03340922` - MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation	Phase 4