Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) (Sphere-9 VT)

September 2, 2026 updated by: Medtronic Cardiac Ablation Solutions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Andre d'Avila, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Srinivas Dukkipati, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Pasquale Santangeli, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Francis Marchlinski, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • William Stevenson, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
        • Contact:
        • Principal Investigator:
          • John David Burkhardt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Any of the following:

    1. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
    2. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
  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 3 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 comply with all pre-, post-, and follow-up testing requirements.

Exclusion Criteria:

  1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
  2. Unstable polymorphic VT or ventricular fibrillation (VF).

  3. VTs due to any of the following:

    1. Idiopathic VT
    2. Automaticity or triggered activity
    3. Lamin or titin genetic mutation
    4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
  4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
  5. VT or VF thought to be from channelopathies.
  6. 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.
  7. Sarcoidosis.
  8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
  9. Unstable angina.
  10. Active myocardial ischemia.
  11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
  12. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
  13. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
  14. Left ventricular ejection fraction (LVEF) <15%.
  15. NYHA Class IV heart failure.
  16. Decompensated heart failure.
  17. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
  18. Ventricular assist device (VAD) implanted, planned or required for the procedure.
  19. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
  20. Presence of prosthetic valve in the aortic or mitral valve.
  21. Patients with advanced COPD (on home oxygen).
  22. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
  23. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
  24. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
  25. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count <80,000).
  26. Contraindication to anticoagulation.
  27. End-stage renal disease (requiring dialysis).
  28. Acute illness, active infection, or sepsis.
  29. Life expectancy less than 12 months.
  30. 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.
  31. Body mass index >45 kg/m2.
  32. Known ongoing drug or alcohol dependency.
  33. 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.
  34. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
  35. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ventricular tachycardia catheter ablation
Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System
Device: Sphere-9 Catheter with the Affera Mapping and Ablation System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Within 7 days post-procedure
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
Day of ablation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Endpoint: assess chronic effectiveness of the index ablation procedure
Time Frame: Within 6 months post-procedure
Percentage of patients free from recurrence of sustained monomorphic ventricular tachycardia
Within 6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Ablation Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sphere-9 VT EFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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