AZ Sint-Jan Brugge-Oostende AV
Bruges, West-Flanders, 8000, Belgium
NCT Number: NCT04773119
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bruges, West-Flanders, 8000, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in this group receive PVI only
Patients in this group receive PVI as well as substrate ablation
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
Time frame: 3 years after ablation
ATA burden after first ablation documented through continuous loop recordings
Time frame: 3 years after ablation
ATA burden after two ablations documented through continuous loop recordings
AZ Sint-Jan AV
Other
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
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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.
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