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NCT Number: NCT04122963

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

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology

Bruges, 8000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High power CLOSE-guided PVI ablation

Procedure

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

Standard CLOSE-guided PVI ablation

Procedure

Standard AF ablation according to the CLOSE-protocol

Primary outcomes

  1. Efficacy: Acute procedural success

    Time frame: At time of ablation

    First pass pulmonary vein isolation confirmed after adenosine injection

  2. Safety: Absence of clinical complications

    Time frame: From time of ablation to 1 month post procedure

    Absence of clinical complications during the procedure and up to one month thereafter

Secondary outcomes

  1. Procedural duration time

    Time frame: At time of ablation

  2. Duration for pulmonary vein isolation

    Time frame: At time of ablation

  3. Fluoroscopic duration and irradiation (AK)

    Time frame: At time of ablation

  4. Amount of ablation points associated with temperature rise

    Time frame: At time of ablation

  5. Maximum temperature in case of temperature rise

    Time frame: At time of ablation

  6. Incidence of adverse events related to ablation

    Time frame: From time of ablation to 6 months post procedure

  7. First pass encirclement isolation rate

    Time frame: At time of ablation

  8. Reconnection rate after adenosine

    Time frame: At time of ablation

  9. Number of dislocations

    Time frame: At time of ablation

  10. Number of ablation points with an oesophageal temperature rise >39°C

    Time frame: At time of ablation

  11. Maximum temperature in case of oesophageal temperature rise

    Time frame: At time of ablation

  12. Longterm procedural success rate

    Time frame: Six months after ablation

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

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

Acronym: POWERAF

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 10, 2019
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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