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

17. september 2026 opdateret af: Medtronic Cardiac Ablation Solutions

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

260

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • Manhasset, New York, Forenede Stater, 11030-3816
        • Rekruttering
        • Northwell Health Lenox Hill Hospital
        • Kontakt:
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-0001
        • Rekruttering
        • Atrium Health Wake Forest Baptist Medical Center
        • Kontakt:
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Rekruttering
        • The Ohio State University Wexner Medical Center
        • Kontakt:
    • Texas
      • Austin, Texas, Forenede Stater, 78705-1852
        • Rekruttering
        • Texas Cardiac Arrhythmia Research Foundation
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ventrikulær takykardi kateterablation
Ablation ved hjælp af Sphere-9 kateteret med Affera Mapping and Ablation System
Enhed: Sphere-9 Catheter with the Affera Mapping and Ablation System
Adult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Safety
Tidsramme: As applicable, within 7 days or 3 months after the index ablation procedure
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.
As applicable, within 7 days or 3 months after the index ablation procedure
Primary Effectiveness
Tidsramme: Through 6 months after the index ablation procedure
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.
Through 6 months after the index ablation procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Cardiac Ablation Solutions

Efterforskere

  • Ledende efterforsker: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai
  • Ledende efterforsker: Pasquale Santangeli, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. august 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Sphere VT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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