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)

Atrial Fibrillation Clinical Trial

— CLOSEMAZE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04773119
• Other study ID #: 2312
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI only
Patients in this group receive PVI only
• PVI with substrate ablation
Patients in this group receive PVI as well as substrate ablation

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge	West-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation	ATA burden after first ablation documented through continuous loop recordings	3 years after ablation
Secondary	Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation	ATA burden after two ablations documented through continuous loop recordings	3 years after ablation