CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications (POWERAF)

CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study

In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: High power CLOSE-guided PVI ablation; Procedure: Standard CLOSE-guided PVI ablation

Detailed Description

BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.

OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.

POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium, 8000
    • Department of cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients referred for symptomatic paroxysmal AF and without advanced structural heart disease
• Signed Patient Informed Consent Form
• Age 18 years or older
• Able and willing to comply with all follow-up testing and requirements

Exclusion Criteria:

• Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
• Previous ablation for AF
• LA antero-posterior diameter>50 mm (parasternal long axis view , PLAX)
• LVEF <35% (ejection fraction)
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• CABG procedure within the last three months
• Awaiting cardiac transplantation or other cardiac surgery
• Documented left atrial thrombus on imaging
• Diagnosed atrial myxoma
• Women who are pregnant or breastfeeding
• Acute illness or active systemic infection or sepsis
• Unstable angina
• Uncontrolled heart failure
• Myocardial infarction within the previous two months
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation therapy (ie, heparin or warfarin)
• Life expectancy less than 12 months
• Enrollment in any other study evaluating another device or drug
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High power group; The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).	Procedure: High power CLOSE-guided PVI ablation; CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
Active Comparator: Standard group; The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)	Procedure: Standard CLOSE-guided PVI ablation; Standard AF ablation according to the CLOSE-protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Acute procedural success	First pass pulmonary vein isolation confirmed after adenosine injection	At time of ablation
Safety: Absence of clinical complications	Absence of clinical complications during the procedure and up to one month thereafter	From time of ablation to 1 month post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedural duration time	At time of ablation
Duration for pulmonary vein isolation	At time of ablation
Fluoroscopic duration and irradiation (AK)	At time of ablation
Amount of ablation points associated with temperature rise	At time of ablation
Maximum temperature in case of temperature rise	At time of ablation
Incidence of adverse events related to ablation	From time of ablation to 6 months post procedure
First pass encirclement isolation rate	At time of ablation
Reconnection rate after adenosine	At time of ablation
Number of dislocations	At time of ablation
Number of ablation points with an oesophageal temperature rise >39°C	At time of ablation
Maximum temperature in case of oesophageal temperature rise	At time of ablation
Longterm procedural success rate	Six months after ablation

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV

Publications and helpful links

General Publications

• Wielandts JY, Kyriakopoulou M, Almorad A, Hilfiker G, Strisciuglio T, Phlips T, El Haddad M, Lycke M, Unger P, Le Polain de Waroux JB, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study. Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

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: 2406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No