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NCT05959798 Clinical Trial

High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: Safety and Acute Procedural Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05959798
Other study ID # POWER PULSE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2019
Est. completion date July 17, 2023

Study information
Verified date July 2023
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date July 17, 2023
Est. primary completion date July 17, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - symptomatic, documented, drug-resistent paroxysmal atrial fibrillation - effective oral anticoagulation Exclusion Criteria: - any prior left atrial ablation procedure - presence of left atrial thrombus - secondary atrial fibrillation due to electrolyte imbalance or thyroid disease - any prior oesophageal or gastric surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• High power short duration ablation
Pulmonary vein isolation by high power short duration radiofrequency catheter ablation

Locations
Country Name City State
Germany Deutsches Herzzentrum München München

Sponsors (1)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups Acute endpoint
Secondary Time to first documented recurrence of atrial fibrillation after a 6-week blanking period. 12 months after ablation
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