NCT04773119Completed
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)
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 10 Feb 2021
- Start date
- 10 Oct 2018
- Primary completion date
- 29 Jul 2024
- Lead sponsor
- AZ Sint-Jan AV
- Diseases
- Atrial fibrillation
- NCT number
- NCT04773119
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 10 Oct 2018 to the primary completion date, 29 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ablation for AF
- Myocardial infarction within the previous two months
- Contraindication to anticoagulation therapy (ie, heparin or warfarin)
- Enrollment in any other study evaluating another device or drug
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Awaiting cardiac transplantation or other cardiac surgery
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Uncontrolled heart failure
- History of blood clotting or bleeding abnormalities
Lab values
- LVEF \< 30% (ejection fraction)
Other
- Longstanding persistent atrial fibrillation (Suspected continuous AF\>1 year)
- left atrial antero-posterior diameter \> 55 mm (parasternal long axis view (PLAX))
- Coronary artery bypass graft within the last three months
- Documented left atrial thrombus on imaging
- Diagnosed atrial myxoma
- Women who are pregnant or breastfeeding
- Life expectancy less than 12 months
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint-Jan Brugge-Oostende AV Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.