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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HL132746-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is an early feasibility, non-randomized, open-label, single group, interventional study to be conducted in up to 20 US subjects to evaluate the technical feasibility of the Durablate Catheter and Thermedical Ablation System to eliminate or control sustained, monomorphic ventricular tachycardia (VT) in patients with VT refractory to drug and conventional catheter ablation with acceptable procedural safety.
The purpose of this study is to gather information on the technical feasiability and safety of a needle ablation catheter called the Durablateâ„¢ Saline Enhanced Radiofrequency (SERF) catheter. This catheter is being studied to treat ventricular tachycardia (VT) in patients who have already been treated with medicine, have an Implantable Cardioverter Defibrillator (ICD) and had an ablation procedure to treat their VT but continue to experience VT despite these treatments. A VT ablation procedure is done by finding the abnormal heart tissue that's causing the VT and applying energy with the tip of an ablation catheter to the area to create a scar or destroy the tissue that causes the VT. The SERF catheter being used in this study uses a needle to deliver heated saline (salt water) and radiofrequency energy deeper into the heart tissue that is causing the VT than a standard ablation catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Enhanced Radiofrequency (SERF) ablation | Device | Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter |
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| Measure | Description | Time Frame |
|---|---|---|
| EFFICACY: Non-inducibility of the targeted clinical VT at end of ablation procedure. | Completion of intended ablation during treatment setting as measured by non-inducibility of the targeted clinical VT (acute procedural success). | By the end of the procedure |
| SAFETY: SAEs that are probably or definitely device related within 30 days | within 30 days |
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Inclusion Criteria:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Packer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35776711 | Result | 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 |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Thermedical SERF Ablation System and Durablate Catheter
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| Rochester |
| Minnesota |
| 55905 |
| United States |
| Vanderbilt Heart | Nashville | Tennessee | 37232 | United States |