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

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

Sponsors

Lead sponsor: AZ Sint-Jan AV

Source 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.

Overall Status Recruiting
Start Date February 15, 2019
Completion Date April 2020
Primary Completion Date September 25, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Efficacy: Acute procedural success At time of ablation
Safety: Absence of clinical complications From time of ablation to 1 month post procedure
Secondary 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
Enrollment 100
Condition
Intervention

Intervention type: Procedure

Intervention name: High power CLOSE-guided PVI ablation

Description: CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)

Arm group label: High power group

Intervention type: Procedure

Intervention name: Standard CLOSE-guided PVI ablation

Description: Standard AF ablation according to the CLOSE-protocol

Arm group label: Standard group

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Michelle Lycke

Phone: 00 32 50 45 32 93

Email: m[email protected]

Location
facility status contact Department of Cardiology Sébastien Knecht, MD, PhD [email protected]
Location Countries

Belgium

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: AZ Sint-Jan AV

Investigator full name: Sebastien Knecht

Investigator title: Professor Doctor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: High power group

Arm group type: Active Comparator

Description: The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).

Arm group label: Standard group

Arm group type: Active Comparator

Description: The control group will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds)

Acronym POWERAF
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov