Belgian public hospital conducts a clinical trial of AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone or Optimized Compartmentalization of the Left Atrium
AZ Sint-Jan AV is recruiting patients for the clinical trial of AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone 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
- 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.
- To assess ATA burden using continuous monitoring up to 3 years after ablation.
- To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.
October 10, 2018 is the study start date. The indicative completion of the clinical trial will be expected in March 31, 2024.
The study will take place at the AZ Sint-Jan Brugge-Oostende AV, Brugge, West-Flanders, Belgium.
Among the excluding conditions appear
- 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
- Uncontrolled heart failure
- Myocardial infarction within the previous two months
- History of blood clotting or bleeding abnormalities
The full list can be viewed at the link below.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04773119
