Randomized Trial: High Power Short Duration Versus Ablation Index

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05251545

Enrollment

176

Registered

2022-02-22

Start date

2021-09-01

Completion date

2023-09-01

Last updated

2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Paroxysmal, Catheter Ablation

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.

Interventions

OTHERPulmonary 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Paroxysmal atrial fibrillation * written informed consent

Exclusion criteria

* inability to obtain written informed consent * persistent atrial fibrillation

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Procedural data	1 year	procedural time

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026