Skip to main content
OpenTrials
Completed

NCT Number: NCT04773119

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan Brugge-Oostende AV

Bruges, West-Flanders, 8000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

PVI only

Procedure

Patients in this group receive PVI only

PVI with substrate ablation

Procedure

Patients in this group receive PVI as well as substrate ablation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study 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

Acronym: CLOSEMAZE

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2021
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.