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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary vein isolation (PVI) only | Active Comparator |
| |
| PVI with substrate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI only | Procedure | Patients in this group receive PVI only |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation | ATA burden after first ablation documented through continuous loop recordings | 3 years after ablation |
| Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation |
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Inclusion Criteria
Patients with symptomatic persistent AF (history of continuous AF > 7 days), meeting following criteria at the out-patient clinic:
Signed Patient Informed Consent Form.
Age 18 years or older.
Able and willing to comply with all follow-up testing and requirements.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien Knecht, MD, PhD | AZ Sint-Jan AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge-Oostende AV | Bruges | West-Flanders | 8000 | Belgium |
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| PVI with substrate ablation |
| Procedure |
Patients in this group receive PVI as well as substrate ablation |
|
ATA burden after two ablations documented through continuous loop recordings
| 3 years after ablation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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