Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation (POWER-PLUS)

AZ Sint-Jan AV

Status and phase

Completed

Phase 4

Conditions

Atrial Fibrillation

Treatments

Procedure: High power short duration pulmonary vein isolation

Procedure: Conventional CLOSE-guided pulmonary vein isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT04784013

2800

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Diagnosed atrial myxoma.
Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Women who are pregnant or who plan to become pregnant during the study.
Acute illness or active infection at time of index procedure
Advanced renal insufficiency
Unstable angina.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation.
Life expectancy less than 1 year.
Presence of a condition that precludes vascular access.
Unwilling or unable to provide informed consent.