Randomized Trial: High Power Short Duration Versus Ablation Index
NCT ID: NCT05251545
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2021-09-01
2023-09-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High power - short duration
Pulmonary vein isolation with high power settings of 45 Watts
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).
Standard energy
Pulmonary vein isolation with standard power settings (30 Watts)
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* persistent atrial fibrillation
18 Years
80 Years
ALL
Yes
Sponsors
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Robert Bosch Medical Center
OTHER
Responsible Party
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Peter Ong, MD
Consultant Cardiologist (in German: Oberarzt)
Principal Investigators
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Peter Ong, Prof
Role: PRINCIPAL_INVESTIGATOR
Robert Bosch Medical Campus
Locations
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Robert Bosch Medical Center
Stuttgart, , Germany
Countries
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Other Identifiers
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High power - short duration
Identifier Type: -
Identifier Source: org_study_id
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