Ventricular TachycardiaNCT07585968
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
A study testing Sphere-9 Catheter with the Affera Mapping and Ablation System in people with Ventricular Tachycardia, run by Medtronic Cardiac Ablation Solutions at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Aug 2026to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior myocardial infarction (MI).
- 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.
- Recurrence of sustained ventricular tachycardia despite Class I or III antiarrhythmic drug therapy or ICD intervention.
- Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure.
- Age 18 through 85 years old.
- Willing and able to provide informed consent.
- Willing and able to comply with all pre-, post-, and follow-up testing requirements.
Who cannot join
- Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- Unstable polymorphic VT or ventricular fibrillation (VF).
- Idiopathic VT or VT of non-ischemic cardiomyopathy.
- VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
- VT or VF thought to be from channelopathies.
- More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
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- Sarcoidosis.
- Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
- Unstable angina.
- Active myocardial ischemia.
- Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
- Any percutaneous coronary intervention performed in a setting of unstable angina or acute MI (STEMI or non-STEMI) within 2 months (60 days) prior to the ablation procedure. Note: elective PCI performed during elective angiogram would be excluded only if occurring within 30 days prior to the ablation procedure.
- Any cardiac surgery within 2 months (60 days) prior to the ablation procedure. Note: ICD lead implant/replacement falls under this exclusion, but ICD generator-only replacement does not.
- Left ventricular ejection fraction (LVEF) <15%.
- NYHA Class IV heart failure.
- Decompensated heart failure.
- Extravascular ICD (EV-ICD) or subcutaneous ICD (S-ICD)
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- Circulatory/ventricular assist device (VAD; surgical or percutaneous) implanted, planned or required for the procedure.
- Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
- Presence of prosthetic valve in the aortic or mitral valve.
- Patients with advanced COPD (on home oxygen).
- Presence of intracardiac tumor or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
- Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
- Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count <80,000).
- Contraindication to anticoagulation.
- End-stage renal disease (requiring dialysis).
- Acute illness, active infection, or sepsis.
- Life expectancy less than 12 months.
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
- Body mass index >45 kg/m2.
- Known ongoing drug or alcohol dependency.
- Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
- Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
- Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
Deb Cardinal, (512) 522-9410, dscardinal@austinheartbeat.com
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240
Adrianne Miller, (614) 688-8252, adrianne.miller3@osumc.edu
- Recruiting
Ascension Saint Vincent Hospital - Indianapolis
Indianapolis, Indiana, 46260
Jennifer Brown, (317) 338-6439, jennifer.brown4@ascension.org
- Recruiting
Northwell Health Lenox Hill Hospital
Manhasset, New York, 11030-3816
Afia Haque, (718) 470-7330, ahaque5@northwell.edu
- Active, not recruiting
NYU Langone Medical Center
New York, New York, 10016-4972
- Recruiting
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157-0001
Keishia Rodriguez, (336) 718-5807, kyrodrig@wakehealth.edu
About this study
Official title: Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
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.
- Conditions
- Ventricular Tachycardia
- Being tested
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Keywords
- Recurrent sustained scar-related monomorphic ventricular tachycardia, Ventricular tachycardia, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Ischemic heart disease, Patient with Implantable Cardioverter Defibrillator (ICD), Ischemic cardiomyopathy
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphere-9 Catheter with the Affera Mapping and Ablation SystemDevice
Adult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular tachycardia catheter ablation | Experimental | Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System Receives: Device: Sphere-9 Catheter with the Affera Mapping and Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through 6 months after the index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start17 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount SinaiPasquale Santangeli, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585968
- Sponsor's protocol ID
- Sphere VT
- Status last verified
- Apr 2026
- First submitted
- 7 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No