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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122963
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastien Knecht, AZ Sint-Jan AV

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE February 15, 2019
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Efficacy: Acute procedural success [ Time Frame: At time of ablation ]
    First pass pulmonary vein isolation confirmed after adenosine injection
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Procedural duration time [ Time Frame: At time of ablation ]
  • Duration for pulmonary vein isolation [ Time Frame: At time of ablation ]
  • Fluoroscopic duration and irradiation (AK) [ Time Frame: At time of ablation ]
  • Amount of ablation points associated with temperature rise [ Time Frame: At time of ablation ]
  • Maximum temperature in case of temperature rise [ Time Frame: At time of ablation ]
  • Incidence of adverse events related to ablation [ Time Frame: From time of ablation to 6 months post procedure ]
  • First pass encirclement isolation rate [ Time Frame: At time of ablation ]
  • Reconnection rate after adenosine [ Time Frame: At time of ablation ]
  • Number of dislocations [ Time Frame: At time of ablation ]
  • Number of ablation points with an oesophageal temperature rise >39°C [ Time Frame: At time of ablation ]
  • Maximum temperature in case of oesophageal temperature rise [ Time Frame: At time of ablation ]
  • Longterm procedural success rate [ Time Frame: Six months after ablation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications
Official Title  ICMJE CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Procedure: High power CLOSE-guided PVI ablation
    CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
  • Procedure: Standard CLOSE-guided PVI ablation
    Standard AF ablation according to the CLOSE-protocol
Study Arms  ICMJE
  • Active Comparator: High power group
    The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds).
    Intervention: Procedure: High power CLOSE-guided PVI ablation
  • 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)
    Intervention: Procedure: Standard CLOSE-guided PVI ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date September 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04122963
Other Study ID Numbers  ICMJE 2406
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sebastien Knecht, AZ Sint-Jan AV
Study Sponsor  ICMJE AZ Sint-Jan AV
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AZ Sint-Jan AV
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP