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This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Single Arm Group to receive ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlexAbility SE Ablation Catheter | Device | Subjects receive ablation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure. | 12 Month | |
| Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation | 12 Month |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical investigation will enroll subjects of all genders who have recurrent, drug-refractory, sustained monomorphic ventricular tachycardia in patients with non-ischemic structural heart disease.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | Clinical Program Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH Healthcare System | Naples | Florida | 34102 | United States | ||
| St. Vincent Hospital |
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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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| Indianapolis |
| Indiana |
| 46240-0970 |
| United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| VA Medical Center Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Baylor Scott & White Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |