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

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ClinicalTrials.gov Identifier: NCT04122963
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sebastien Knecht, 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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: High power CLOSE-guided PVI ablation Procedure: Standard CLOSE-guided PVI ablation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High power group
The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).
Procedure: High power CLOSE-guided PVI ablation
CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122963


Contacts
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Contact: Michelle Lycke 00 32 50 45 32 93 michelle.lycke@azsintjan.be

Locations
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Belgium
Department of Cardiology Recruiting
Bruges, Belgium, 8000
Contact: Sébastien Knecht, MD, PhD       sebastien.knecht@azsintjan.be   
Sponsors and Collaborators
AZ Sint-Jan AV

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Responsible Party: Sebastien Knecht, Professor Doctor, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT04122963     History of Changes
Other Study ID Numbers: 2406
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes