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)

NCT04773119 | Completed

• 1 other identifier: 2312
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess ATA burden using continuous monitoring up to 3 years after ablation.
3. 3.To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation

  3 years after ablation

• Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation

  3 years after ablation

Study Arms (2)

Pulmonary vein isolation (PVI) only

ACTIVE COMPARATOR

Procedure: PVI only

PVI with substrate

ACTIVE COMPARATOR

Procedure: PVI with substrate ablation

Interventions

PVI only PROCEDURE

Patients in this group receive PVI only

Pulmonary vein isolation (PVI) only

PVI with substrate ablation PROCEDURE

Patients in this group receive PVI as well as substrate ablation

PVI with substrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all follow-up testing and requirements.

You may not qualify if:

• Longstanding persistent atrial fibrillation (Suspected continuous AF\>1 year)
• Previous ablation for AF
• left atrial antero-posterior diameter \> 55 mm (parasternal long axis view (PLAX))
• LVEF \< 30% (ejection fraction)
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Coronary artery bypass graft 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, West-Flanders, 8000, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 26, 2021
• Study Start: October 10, 2018
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)