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Completed

NCT Number: NCT05251545

Randomized Trial: High Power Short Duration Versus Ablation Index

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).

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Key information

Conditions

Atrial Fibrillation Paroxysmal Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Bosch Medical Center

Stuttgart, 70376, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Paroxysmal atrial fibrillation
  • written informed consent

Exclusion criteria

  • inability to obtain written informed consent
  • persistent atrial fibrillation

Treatment and study plan

Pulmonary vein isolation

Other

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).

Primary outcomes

  1. Single procedure success rate, identified by 48-hours Holder-ECGs every three months

    Time frame: 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 outcomes

  1. Procedural data

    Time frame: 1 year

    procedural time

Sponsors and collaborators

Lead sponsor

Robert Bosch Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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