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New heart catheter aims to tame Life-Threatening rhythm disorder

NCT ID NCT07585968

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study tests a new device (Sphere-9 catheter and Affera system) to treat ventricular tachycardia, a fast, dangerous heart rhythm, in 260 adults who have had a heart attack. Participants must have had repeated episodes despite medication or a defibrillator. The goal is to see if the procedure safely stops these episodes without needing stronger drugs for at least 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. Idiopathic VT or VT of non-ischemic cardiomyopathy. 4. VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia). 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 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. 13. 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. 14. Left ventricular ejection fraction (LVEF) \<15%. 15. NYHA Class IV heart failure. 16. Decompensated heart failure. 17. Extravascular ICD (EV-ICD) or subcutaneous ICD (S-ICD) 18. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO). 19. Circulatory/ventricular assist device (VAD; surgical or percutaneous) implanted, planned or required for the procedure. 20. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation. 21. Presence of prosthetic valve in the aortic or mitral valve. 22. Patients with advanced COPD (on home oxygen). 23. Presence of intracardiac tumor or other abnormality that precludes vascular access, catheter introduction, or manipulation. 24. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit. 25. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging. 26. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000). 27. Contraindication to anticoagulation. 28. End-stage renal disease (requiring dialysis). 29. Acute illness, active infection, or sepsis. 30. Life expectancy less than 12 months. 31. 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. 32. Body mass index \>45 kg/m2. 33. Known ongoing drug or alcohol dependency. 34. 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. 35. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship). 36. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157-0001, United States

  • Northwell Health Lenox Hill Hospital

    RECRUITING

    Manhasset, New York, 11030-3816, United States

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705-1852, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210-1240, United States

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