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Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventricular tachycardia catheter ablation | Experimental | Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphere-9 Catheter with the Affera Mapping and Ablation System | Device | Adult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety | A pre-defined list of device- or procedure-related SAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event. | As applicable, within 7 days or 3 months after the index ablation procedure |
| Primary Effectiveness | Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) through 6 months after the index ablation procedure. | Through 6 months after the index ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josh Treadway | Contact | 817-412-0608 | josh.b.treadway@medtronic.com | |
| Analyn Jackson | Contact | 214-697-9894 | analyn.u.jackson@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Pasquale Santangeli, MD | The Cleveland Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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