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Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (>4 episodes within 6 months, two episodes >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).
Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.
Outcomes:
Followup:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI group | Other | Trigger-based ablation guided by pulmonary vein antrum isolation |
|
| CFAE group | Other | Substrate-based ablation using an approach targeting CFAEs |
|
| Combined group | Other | Combined trigger and substrate based approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablate AF triggers via PVI | Procedure | Trigger-based ablation guided by pulmonary vein antrum isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications. | 3 months | |
| Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure. | 12 months | |
| Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, Dr. | Southlake Regional health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada | ||
| Montreal Heaert Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20215126 | Derived | Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Substrate via CFAEs | Procedure | Substrate-based ablation using an approach targeting CFAEs |
|
| Combined approach for AF ablation | Procedure | Combined trigger and substrate based approach |
|
| Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death. | 12 months |
| Procedure duration at ablation. | At intervention |
| Fluoroscopy time at ablation. | At intervention |
| Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure. | 12 months |
| Montreal |
| Quebec |
| H1T 1C8 |
| Canada |
| McMaster University | Hamilton | L8L 2X2 | Canada |
| Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee | Victoria | V8R 4R2 | Canada |
| Clinica Santa Maria | Bari | Apulia | 70124 | Italy |
| Ospedale Regionale Ca'Foncello | Treviso | 31100 | Italy |
| Haukeland Universitetssykehus | Bergen | Haukeland | 5021 | Norway |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |