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This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI + Lines Ablation | Experimental |
| |
| PVI Ablation | Active Comparator |
| |
| PVI + CFE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI + Lines ablation | Procedure | Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF | Freedom from documented AF episodes > 30 seconds at 18 months after one or two ablation procedure with/without antiarrhythmic medications (AAD). In the CT.gov website and in our protocol, we have stated the above primary endpoint (PE). This was the identical PE used in the original STAR AF I study. The intent of this PE was to present the success rates after both 1 procedure and after 2 procedures separately as was done in the original STAR AF I study. However, this is not entirely clear from the way the PE is stated. It may appear that our PE is the success rate after 2 procedures ("1 or 2" may imply "2"). Since our sample size calculation for the STAR AF II study was based on a single procedure success rate, the single procedure success rate with/without AAD will be used as the PE. The success rate after 2 procedures will be provided as the 1st. secondary endpoint. This clarification is done prior to locking the database and prior to any data analysis. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmia | Freedom from documented atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications | 18 months |
| Freedom from atrial flutter and AT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, Dr. | Southlake Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Andrews War Memorial Hospital | Brisbane | Queensland | Australia | |||
| Southlake Regional Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33275151 | Derived | Terricabras M, Mantovan R, Jiang CY, Betts TR, Chen J, Deisenhofer I, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A; Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II) Investigators. Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2025473. doi: 10.1001/jamanetworkopen.2020.25473. | |
| 25946280 |
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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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| PVI | Procedure | Pulmonary vein antrum isolation |
|
| PVI + CFE ablation | Procedure | Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation |
|
Freedom from documented atrial flutter and atrial tachycardia episodes > 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications
| 18 months |
| Freedom from documented or not atrial arrhythmia | Freedom from any atrial arrhythmia (documented or not) episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications | 18 months |
| Freedom from symptomatic AF | Freedom from symptomatic AF episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications | 18 months |
| Freedom from symptomatic atrial arrhythmia | Freedom from symptomatic atrial arrhythmia episodes > 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications | 18 months |
| Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death | Incidence of peri-procedural complications, including stroke, PV stenosis, cardiac perforation, esophageal injury and death | 18 months |
| Procedure duration and fluoroscopy time | Procedure duration and fluoroscopy time | 18 months |
| Number of repeat procedures | Number of repeat procedures | 18 months |
| Effect of each strategy on AF cycle length/regularity/termination | Effect of each strategy on AF cycle length/regularity/termination | 18 months |
| Relationship of acute termination of AF to long-term procedural outcome | Relationship of acute termination of AF to long-term procedural outcome | 18 months |
| Percentage achievement of complete linear block in linear ablation arm | Percentage achievement of complete linear block in linear ablation arm | 18 months |
| Effect of complete linear block on procedural outcome in linear ablation arm | Effect of complete linear block on procedural outcome in linear ablation arm | 18 months |
| Quality of life measurements (SF-36, EQ-5D and CCS SAF) | Quality of life measurements (SF-36, EQ-5D and CCS SAF) at baseline, 6, 12 and 18 months after one and/or two ablation procedures | 18 MONTHS |
| Correlation of AF burden to symptoms and quality of life changes | Correlation of AF burden to symptoms and quality of life changes | 18 Months |
| Improvement in AF burden by > 90% post ablation procedure | Improvement in AF burden by > 90% post ablation procedure | 18 months |
| Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome | Relationship of ablating all atrial arrhythmias versus ablation of only targeted endpoints on long term outcome | 18 months |
| Cut off of AF burden that affects the Quality of Life measurement | Cut off of AF burden that affects the Quality of Life measurement | 18 months |
| Evaluation of cost utility | Evaluation of cost utility | 18 months |
| Newmarket |
| Ontario |
| L3Y 8C3 |
| Canada |
| Derived |
| Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288. |
| 22795275 | Derived | Verma A, Sanders P, Macle L, Deisenhofer I, Morillo CA, Chen J, Jiang CY, Ernst S, Mantovan R. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II (STAR AF II): design and rationale. Am Heart J. 2012 Jul;164(1):1-6.e6. doi: 10.1016/j.ahj.2012.04.002. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |