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

Atrial Fibrillation Clinical Trial

— POWERAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122963
• Other study ID #: 2406
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• High power CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
• Standard CLOSE-guided PVI ablation
Standard AF ablation according to the CLOSE-protocol

Locations

Country	Name	City	State
Belgium	Department of Cardiology	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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-Gu — View Citation

Outcome

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