Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Medtronic Cardiac Ablation Solutions
Summary
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Prior myocardial infarction (MI). 2. At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment. 3. Recurrence of sustained ventricular tachycardia despite Class I or III antiarrhythmic drug therapy or ICD intervention. 4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure. 5. Age 18 through 85 years old. 6. Willing and able to provide informed consent. 7. Willing and able to…
Interventions
- DeviceSphere-9 Catheter with the Affera Mapping and Ablation System
Adult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.
Locations (2)
- The Ohio State University Wexner Medical CenterColumbus, Ohio
- Texas Cardiac Arrhythmia Research FoundationAustin, Texas