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

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

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

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: High power short duration ablation

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 80636
    • Deutsches Herzzentrum München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High power short duration ablation	Procedure: High power short duration ablation; Pulmonary vein isolation by high power short duration radiofrequency catheter ablation
Moderate power long duration ablation	Procedure: High power short duration ablation; Pulmonary vein isolation by high power short duration radiofrequency catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups	Acute endpoint

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.	12 months after ablation

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Isabel Deisenhofer, Prof. Dr., Deutsches Herzzentrum München, Abt. für Elektrophysiologie

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2019
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: POWER PULSE

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