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| Name | Class |
|---|---|
| Applied Health Research Centre | OTHER |
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Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact Force Sensing (CFS) Blinded | Active Comparator | Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) |
|
| Contact Force Sensing (CFS) Guided | Active Comparator | Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermoCoolSmartTouch ablation catheter, Biosense Webster | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cumulative radio frequency (RF) delivery time | Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF or atrial arrhythmia >30 sec | Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation | 12 months |
| Ability to achieve PV isolation with a single ring of lesions around each PV |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, MD | Southlake Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Island Cardiac Arrhythmia Clinic | Victoria | British Columbia | V8R 4R2 | Canada | ||
| Southlake Regional Health Centre |
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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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Ability to achieve PV isolation with a single ring of lesions around each PV
| 6 hours |
| Ability to achieve linear ablation with complete conduction block on the first attempt | Ability to achieve linear ablation with complete conduction block on the first attempt | 6 hours |
| Number & location of conduction gaps after initial circumferential ablation lines | Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure | 6 hours |
| Number & location of conduction gaps after initial linear ablation | Number & location of conduction gaps after initial linear ablation during first ablation procedure | 6 hours |
| Time required for successful PV isolation | Time required for successful PV isolation taking into consideration all ablation procedures | 12 months |
| Time required for successful linear ablation | Time required for successful linear ablation taking into consideration all ablation procedures | 12 months |
| Total fast anatomical mapping (FAM) time | Total FAM time taking into consideration all ablation procedures | 12 months |
| FAM volume | FAM volume of CFS vs non-CFS guided maps | 12 months |
| Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis | Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis | 90 days |
| Incidence of repeat ablation procedures | 12 months |
| Incidence of conduction gaps around pulmonary veins | Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps | 12 months |
| Freedom from atrial arrhythmia > 30 sec | Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure | 12 months |
| Freedom from atrial arrhythmia > 30 sec after one or two procedures | Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures | 12 months |
| Reduction in atrial arrhythmia burden by >90% | 12 months |
| Newmarket |
| Ontario |
| L3Y 2P9 |
| Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Laval University Cardiac and Pulmonary Institute | Québec | Quebec | G1V 0A6 | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |