Clinical trial NCT04122963: CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications
Official title: CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 100
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Acute procedural success
timeFrame: At time of ablation
measure: Safety: Absence of clinical complications
timeFrame: From time of ablation to 1 month post procedure
Secondary outcomes:
measure: Procedural duration time
timeFrame: At time of ablation
measure: Duration for pulmonary vein isolation
timeFrame: At time of ablation
measure: Fluoroscopic duration and irradiation (AK)
timeFrame: At time of ablation
measure: Amount of ablation points associated with temperature rise
timeFrame: At time of ablation
measure: Maximum temperature in case of temperature rise
timeFrame: At time of ablation
measure: Incidence of adverse events related to ablation
timeFrame: From time of ablation to 6 months post procedure
measure: First pass encirclement isolation rate
timeFrame: At time of ablation
measure: Reconnection rate after adenosine
timeFrame: At time of ablation
measure: Number of dislocations
timeFrame: At time of ablation
measure: Number of ablation points with an oesophageal temperature rise >39°C
timeFrame: At time of ablation
measure: Maximum temperature in case of oesophageal temperature rise
timeFrame: At time of ablation
measure: Longterm procedural success rate
timeFrame: Six months after ablation
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: Department of Cardiology
Study officials:
References:
citation: 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.