New heart catheter aims to tame Life-Threatening rhythm disorder
NCT ID NCT07585968
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
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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
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Atrium Health Wake Forest Baptist Medical Center
RECRUITINGWinston-Salem, North Carolina, 27157-0001, United States
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Northwell Health Lenox Hill Hospital
RECRUITINGManhasset, New York, 11030-3816, United States
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Texas Cardiac Arrhythmia Research Foundation
RECRUITINGAustin, Texas, 78705-1852, United States
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The Ohio State University Wexner Medical Center
RECRUITINGColumbus, Ohio, 43210-1240, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two advanced heart maps guide a more precise fix for dangerous arrhythmias?
- Could a short course of steroids calm a dangerous heart rhythm?
- CT scan roadmap may improve heart ablation success
- 4,000 heart patients to be tracked after ablation procedure