Clinical trial NCT04784013: Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation
Official title: Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Procedural time
timeFrame: Procedure (At time of ablation)
Secondary outcomes:
measure: Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation
timeFrame: Months 4-6 after ablation
measure: Radiofrequency (RF) ablation time
timeFrame: Procedure (At time of ablation)
measure: Fluoroscopy dose
timeFrame: Procedure (At time of ablation)
measure: First pass isolation rate
timeFrame: Procedure (At time of ablation)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Hospital Graz
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
state: Please Select
city: Leiden
country: Netherlands
facility: UMC Leiden
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: AZ Sint-Jan AV
name: Mattias Duytschaever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: