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AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique) (CLOSEMAZE)

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ClinicalTrials.gov Identifier: NCT04773119
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sebastien Knecht, AZ Sint-Jan AV

Study Description
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Brief Summary:

Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (AF). However, persistent AF represent a broad spectrum of the same disease and if PV isolation may be sufficient for some patient with self-terminated AF or with a small left atrium, a more extended substrate ablation may be required for other patients, for which a second procedure for atrial tachycardia (AT) recurrence is then frequently needed. In addition, a lot of progress has recently been made in the field of ablation techniques using contiguous and optimized ablation radiofrequency (RF) lesions and also for AT mapping with promising results using repetitive but discontinuous Holter monitoring.

This trial aims at

  1. To objectively compare atrial tachyarrhythmia (ATA) burden > 2 months before ablation and after one or two 'CLOSEMAZE'-guided ablation(s) using continuous monitoring and echo data as a guide for the ablation strategy during the first ablation.
  2. To assess ATA burden using continuous monitoring up to 3 years after ablation.
  3. To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: PVI only Procedure: PVI with substrate ablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique): the CLOSEMAZE Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pulmonary vein isolation (PVI) only Procedure: PVI only
Patients in this group receive PVI only
Active Comparator: PVI with substrate Procedure: PVI with substrate ablation
Patients in this group receive PVI as well as substrate ablation


Outcome Measures
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Primary Outcome Measures :
  1. Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy [ Time Frame: CLR implant to 3 year post ablation ]
    ATA burden (= time that a subject experiences AF) will be monitored with continuous loop recording (CLR) from time of CLR implant until 3 years after ablation


Secondary Outcome Measures :
  1. Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation [ Time Frame: 3 years after ablation ]
    ATA burden after first ablation documented through continuous loop recordings

  2. Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation [ Time Frame: 3 years after ablation ]
    ATA burden after two ablations documented through continuous loop recordings


Eligibility Criteria
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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

  1. Patients with symptomatic persistent AF (history of continuous AF > 7 days), meeting following criteria at the out-patient clinic:

    • patient has AF at the time of the visit
    • AF episodes are symptomatic, and patient is drug-resistant (at least one class Ic or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,…)
    • If the patient has heart failure (LVEF<50%), first line AF ablation (instead of amiodarone) is indicated
  2. Signed Patient Informed Consent Form.
  3. Age 18 years or older.
  4. Able and willing to comply with all follow-up testing and requirements.

Exclusion Criteria

  1. Longstanding persistent atrial fibrillation (Suspected continuous AF>1 year)
  2. Previous ablation for AF
  3. left atrial antero-posterior diameter > 55 mm (parasternal long axis view (PLAX))
  4. LVEF < 30% (ejection fraction)
  5. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  6. Coronary artery bypass graft within the last three months
  7. Awaiting cardiac transplantation or other cardiac surgery
  8. Documented left atrial thrombus on imaging
  9. Diagnosed atrial myxoma
  10. Women who are pregnant or breastfeeding
  11. Acute illness or active systemic infection or sepsis
  12. Unstable angina
  13. Uncontrolled heart failure
  14. Myocardial infarction within the previous two months
  15. History of blood clotting or bleeding abnormalities
  16. Contraindication to anticoagulation therapy (ie, heparin or warfarin)
  17. Life expectancy less than 12 months
  18. Enrollment in any other study evaluating another device or drug
  19. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
Contacts and Locations
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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): NCT04773119


Contacts
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Contact: Sébastien Knecht, MD, PhD +32 50 45 26 70 sebastien.knecht@azsintjan.be
Contact: Michelle Lycke, MSc, PhD +32 50 45 32 93 michelle.lycke@azsintjan.be

Locations
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Belgium
AZ Sint-Jan Brugge-Oostende AV Recruiting
Brugge, West-Flanders, Belgium, 8000
Contact: Michelle Lycke, MSc, PhD    +32 50 45 32 93    michelle.lycke@azsintjan.be   
Principal Investigator: Sébastien Knecht, MD, PhD         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Sébastien Knecht, MD, PhD AZ Sint-Jan AV
More Information
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Responsible Party: Sebastien Knecht, Principal Investigator, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT04773119    
Other Study ID Numbers: 2312
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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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