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The purpose of this study is to demonstrate the technical feasibility of the SERF Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SERF Catheter Ablation | Experimental | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline-Enhanced Radiofrequency Catheter and Ablation System | Device | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events that are potentially device-related | Within 30 days of ablation | |
| Major Adverse Cardiac Events | MACE will be accessed from time of ablation to time of discharge from hospital following the ablation (generally within 2 days of ablation procedure). | Within 2 days after ablation procedure |
| Non-inducibility of clinical ventricular tachycardia (VT) and/or elimination of clinically relevant scar or channels | At completion of ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intraprocedural non-inducibility and/or scar homogenization of target VT | At completion of ablation procedure | |
| Elimination of the target VT and/or reduction in number of VT episodes | Within first 6 months of ablation procedure |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Douglas L. Packer, MD | Mayo Clinic | Study Director |
| Atul Verma, MD | Southlake Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y-2P6 | Canada | ||
| Montreal Heart Institute - Institut de Cardiologie de Montréal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35776711 | Derived | Packer DL, Wilber DJ, Kapa S, Dyrda K, Nault I, Killu AM, Kanagasundram A, Richardson T, Stevenson W, Verma A, Curley M; SERF Investigators. Ablation of Refractory Ventricular Tachycardia Using Intramyocardial Needle Delivered Heated Saline-Enhanced Radiofrequency Energy: A First-in-Man Feasibility Trial. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e010347. doi: 10.1161/CIRCEP.121.010347. Epub 2022 Jul 1. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Montreal |
| Quebec |
| H1T 1C8 |
| Canada |
| Quebec Heart and Lung Institute - Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Canada |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |