Randomized Trial: High Power Short Duration Versus Ablation Index

August 1, 2025 updated by: Peter Ong, MD, Robert Bosch Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70376
        • Robert Bosch Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Paroxysmal atrial fibrillation
  • written informed consent

Exclusion Criteria:

  • inability to obtain written informed consent
  • persistent atrial fibrillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High power - short duration
Pulmonary vein isolation with high power settings of 45 Watts
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).
Active Comparator: Standard energy
Pulmonary vein isolation with standard power settings (30 Watts)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural data
Time Frame: 1 year
procedural time
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Bosch Medical Center

Investigators

  • Principal Investigator: Peter Ong, Prof, Robert Bosch Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High power - short duration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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