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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Standard CLOSE-guided PVI ablation; Procedure: High power CLOSE-guided PVI ablation

• Registration Number: NCT04122963
• Lead Sponsor: AZ Sint-Jan AV

Brief 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).

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 Timeline

• Study Start: 2019-02-15
• Primary Completion: 2019-09-25
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Study Completion: 2020-06-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard group	Standard CLOSE-guided PVI ablation	The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)
High power group	High power CLOSE-guided PVI ablation	The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Procedural duration time	At time of ablation
Number of ablation points with an oesophageal temperature rise >39°C	At time of ablation
Number of dislocations	At time of ablation
Maximum temperature in case of oesophageal temperature rise	At time of ablation
Longterm procedural success rate	Six months after 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
Reconnection rate after adenosine	At time of ablation
First pass encirclement isolation rate	At time of ablation

Trial Locations

Locations (1)

Department of Cardiology; 🇧🇪 Bruges, Belgium