Ventricular Tachycardia (VT)NCT06703489
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
A study testing Sphere-9 Catheter with the Affera Mapping and Ablation System in people with Ventricular Tachycardia (VT), run by Medtronic Cardiac Ablation Solutions at 6 sites in United States.
Trial summary
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia 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 (VT)
- 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
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Mar 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Any of the following:
- Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
- Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
- 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 3 months prior to the ablation procedure.
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- 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).
- VTs due to any of the following:
- Idiopathic VT
- Automaticity or triggered activity
- Lamin or titin genetic mutation
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- Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
- NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
- 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.
- 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 within 2 months (60 days) prior to the ablation procedure.
- Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
- Left ventricular ejection fraction (LVEF) <15%.
- NYHA Class IV heart failure.
- Decompensated heart failure.
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- Ventricular assist device (VAD) 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 thrombus, 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, 6 recruiting
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Deb Cardinal, 512-522-9410, dscardinal@austinheartbeat.com
John David Burkhardt, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jenifer Kaufman, (617) 632-8956, jmkaufma@bidmc.harvard.edu
Andre d'Avila, MD
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Jill Kandrac, (216) 444-2521, kandraj@ccf.org
Pasquale Santangeli, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Terry Weyand, 615-322-9349, terry.l.weyand@vumc.org
William Stevenson, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Betsy Ellsworth, (212) 241-6500, betsy.ellsworth@mountsinai.org
Srinivas Dukkipati, MD
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Gnap, (215) 349-8446, Mary.gnap@pennmedicine.upenn.edu
Francis Marchlinski, MD
About this study
Official title: Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
- Conditions
- Ventricular Tachycardia (VT)
- Being tested
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Keywords
- Recurrent sustained monomorphic ventricular tachycardia, 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 recurrent, sustained, scar-related monomorphic 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 Endpoint: evaluate the safety of the index ablation procedure
Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events
Measured: Within 7 days post-procedure
Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
Percentage of patients whose targeted clinically relevant monomorphic ventricular tachycardia cannot be induced
Measured: Day of ablation procedure
Secondary outcomes (1)
Secondary Endpoint: assess chronic effectiveness of the index ablation procedure
Percentage of patients free from recurrence of sustained monomorphic ventricular tachycardia
Measured: Within 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start18 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- 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
- 60 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 Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703489
- Sponsor's protocol ID
- Sphere-9 VT EFS
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT06703489
- Acronym / sponsor ID
- Sphere-9 VT EFS
- Conditions
- Ventricular Tachycardia (VT)
- Keywords
- Recurrent sustained monomorphic ventricular tachycardia, Monomorphic ventricular tachycardia, Ventricular tachycardia, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes, Ischemic heart disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventricular tachycardia catheter ablation | Experimental | Device: Sphere-9 Catheter with the Affera Mapping and Ablation SystemAblation using the Sphere-9 Catheter with the Affera Mapping and Ablation System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Any of the following:
- 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 3 months prior to the ablation procedure.
- Age 18 through 85 years old.
Key exclusion criteria (39 listed)
- Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- Unstable polymorphic VT or ventricular fibrillation (VF).
- VTs due to any of the following:
- NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
- VT or VF thought to be from channelopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphere-9 Catheter with the Affera Mapping and Ablation SystemAdult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System. | Device | Ventricular tachycardia catheter ablation |
Primary outcome
Primary Safety Endpoint: evaluate the safety of the index ablation procedure
Time frame: Within 7 days post-procedure
Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events
Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
Time frame: Day of ablation procedure
Percentage of patients whose targeted clinically relevant monomorphic ventricular tachycardia cannot be induced
1 secondary outcome
Secondary Endpoint: assess chronic effectiveness of the index ablation procedure
Time frame: Within 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia (VT)
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Not yet recruiting
Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Scar-related Monomorphic Sustained VT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sphere-9 Catheter with the Affera Mapping and Ablation System in people with Ventricular Tachycardia (VT), run by Medtronic Cardiac Ablation Solutions at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josh Treadway (817-412-0608, josh.b.treadway@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: evaluate the safety of the index ablation procedure (time frame: Within 7 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.