Randomized Trial: High Power Short Duration Versus Ablation Index

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation Paroxysmal; Catheter Ablation
• Interventions: Other: Pulmonary vein isolation

• Registration Number: NCT05251545
• Lead Sponsor: Robert Bosch Medical Center

Brief 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).

Detailed 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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Paroxysmal atrial fibrillation
• written informed consent

Exclusion Criteria

• inability to obtain written informed consent
• persistent atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High power - short duration	Pulmonary vein isolation	Pulmonary vein isolation with high power settings of 45 Watts
Standard energy	Pulmonary vein isolation	Pulmonary vein isolation with standard power settings (30 Watts)

Primary Outcome Measures

Name	Time	Method
Single procedure success rate, identified by 48-hours Holder-ECGs every three months	1 year	Freedom of any atrial arrhythmia of more than 30 sec during a follow-up period of 12 months after the first procedure.

Secondary Outcome Measures

Name	Time	Method
Procedural data	1 year	procedural time

Trial Locations

Locations (1)

Robert Bosch Medical Center; 🇩🇪 Stuttgart, Germany