Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Conventional CLOSE-guided pulmonary vein isolation; Procedure: High power short duration pulmonary vein isolation

• Registration Number: NCT04784013
• Lead Sponsor: AZ Sint-Jan AV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Study Start: 2021-03-24
• Primary Completion: 2021-10-22
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	Conventional CLOSE-guided pulmonary vein isolation	-
90W-group	High power short duration pulmonary vein isolation	-

Primary Outcome Measures

Name	Time	Method
Procedural time	Procedure (At time of ablation)	Comparison of the procedural time (in minutes) between groups

Secondary Outcome Measures

Name	Time	Method
Single procedure atrial tachyarrhythmia freedom between months 4, 5 and 6 after the index ablation	Months 4-6 after ablation	Atrial tachyarrhythmia will be monitored by Holter
Radiofrequency (RF) ablation time	Procedure (At time of ablation)	Comparison of the RF ablation time (in seconds) between groups
First pass isolation rate	Procedure (At time of ablation)	Reconnection of the veins after adenosine injection or waiting time
Fluoroscopy dose	Procedure (At time of ablation)	Comparison of the fluoroscopy dose (Gy cm²) between groups

Trial Locations

Locations (4)

Medical University Hospital Graz; 🇦🇹 Graz, Austria

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, Please Select, Belgium

UMC Leiden; 🇳🇱 Leiden, Netherlands

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland