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)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI only; Procedure: PVI with substrate ablation

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • West-Flanders
    • Brugge, West-Flanders, Belgium, 8000
      • AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy	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	CLR implant to 3 year post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation	ATA burden after first ablation documented through continuous loop recordings	3 years after ablation
Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation	ATA burden after two ablations documented through continuous loop recordings	3 years after ablation

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Sébastien Knecht, MD, PhD, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No