Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study

AZ Sint-Jan AV4 sites in 4 countries182 target enrollmentMarch 24, 2021

ConditionsAtrial Fibrillation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: AZ Sint-Jan AV
Enrollment: 182
Locations: 4
Primary Endpoint: Procedural time
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

Registry

clinicaltrials.gov

Start Date

March 24, 2021

End Date

May 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AZ Sint-Jan AV

Responsible Party

Principal Investigator

Prof. Dr. Mattias Duytschaever

Principal Investigator

AZ Sint-Jan AV

Eligibility Criteria

Inclusion Criteria

•Patients older than 18 years
•Patients scheduled for a first PVI only for paroxysmal atrial fibrillation (AF) (self-terminating or \<7days) or persistent AF (persistent AF is defined as having an AF episode \>7d); (patients with paroxysmal AF or short-standing persistent AF presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial)
•Patients willing to sign informed consent

Exclusion Criteria

•Patients with long-standing persistent AF (long-standing persistent AF is defined as having an AF episode \>1yr)
•Previous ablation for AF
•Left atrium antero-posterior diameter \>50 mm (parasternal long axis view, PLAX)
•AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
•Left atrial appendage (LAA) thrombus. LAA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
•Left ventricular ejection fraction \<35%.
•Cardiac surgery within the previous 90 days.
•Expecting cardiac transplantation or other cardiac surgery within 180 days.
•Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
•Documented history of a thromboembolic event within the previous 90 days.

Outcomes

Primary Outcomes

Procedural time

Time Frame: Procedure (At time of ablation)

Comparison of the procedural time (in minutes) between groups

Secondary Outcomes

Radiofrequency (RF) ablation time(Procedure (At time of ablation))
First pass isolation rate(Procedure (At time of ablation))
Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation(Months 4-6 after ablation)
Fluoroscopy dose(Procedure (At time of ablation))