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NCT05251545 Clinical Trial

Randomized Trial: High Power Short Duration Versus Ablation Index

Catheter Ablation Clinical Trial

Official title:
Pulmonary Vein Isolation Using High Power - Short Duration Versus Ablation Index: a Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05251545
Other study ID # High power - short duration
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2023

Study information
Verified date March 2023
Source Robert Bosch Medical Center
Contact Peter Ong, Prof
Phone 004971181010
Email peter.ong@rbk.de
Is FDA regulated No
Health authority
Study type Interventional

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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 88
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Paroxysmal atrial fibrillation - written informed consent Exclusion Criteria: - inability to obtain written informed consent - persistent atrial fibrillation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pulmonary vein isolation
Comparison of power levels in catheter ablation in regard of single procedure success rate (freedom of any atrial arrhythmia with a duration of more than 30 sec. 45 Watts versus standard power levels (30 Watts).

Locations
Country Name City State
Germany Robert Bosch Medical Center Stuttgart

Sponsors (1)
Lead Sponsor Collaborator
Robert Bosch Medical Center

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single procedure success rate, identified by 48-hours Holder-ECGs every three months Freedom of any atrial arrhythmia of more than 30 sec during a follow-up period of 12 months after the first procedure. 1 year
Secondary Procedural data procedural time 1 year
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