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Cryoablation for Monomorphic Ventricular Tachycardia (VTS) (FULCRUM-VT)

11. juni 2026 opdateret af: Adagio Medical

Cryoablation for Monomorphic Ventricular Tachycardia IDE Study

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A prospective, single-arm, multi-center, open label, pre-market, clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients. Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation. Study subjects must have an Implantable Cardioverter Defibrillator (ICD) prior to the cryoablation procedure.

The VTS study is being initiated to collect safety and effectiveness data and support future PMA supplement marketing application.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

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

  • Canada
      • Montreal, Canada
        • Montreal Hear Institute
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre (MUHC), Montreal General Hospital (MGH)
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Banner University Medical Center Phoenix
    • California
      • Long Beach, California, Forenede Stater, 90806
        • MemorialCare Long Beach Medical Center
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
    • New York
      • Staten Island, New York, Forenede Stater, 10305
        • Northwell Health- Staten Island University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29403
        • Medical Center of South Carolina (MUSC)
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23219

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:

  • IC 1 Male or female ≥ 18 years
  • IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.

  • IC 3 Any of the following:

    • Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF < 50%.
    • non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF < 50%
    • Arrhythmogenic right ventricular cardiomyopathy (ARVC)
  • IC 4 Has received a market-released ICD prior to enrollment
  • IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
  • IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)
  • IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
  • IC 8 Willingness and ability to give an informed consent

Exclusion Criteria:

  • EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
  • EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use

  • EC 3 VTs due to any of the following causes:

    1. Idiopathic VT
    2. Automaticity or triggered activity
    3. Bundle Branch Reentry (BBR)
    4. Any focal tachycardia (e.g., papillary, RVOT)
    5. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause

  • EC 4 NICM patients only, if any of the following apply:

    1. Congenital condition that limits access to the left or right ventricles
    2. Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
    3. Active inflammatory processes (e.g., myocarditis) within the past 120 days
    4. Sarcoidosis
    5. Hypertrophic cardiomyopathy
    6. Drug- or alcohol-induced cardiomyopathy
  • EC 5 Any VT ablation within 4 weeks prior to enrollment
  • EC 6 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
  • EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT

  • EC 8 Any other cardiovascular conditions as described below:

    1. Class IV heart failure
    2. Aortic aneurysm
    3. Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
    4. Interatrial baffle, closure device, patch, or PFO occlusion device
    5. Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
    6. Acute MI or unstable angina in the previous 60 days
    7. Mechanical mitral or aortic valve
    8. Cardiac myxoma
    9. Significant congenital heart disease
  • EC 9 Acute illness or active systemic infection
  • EC 10 Any previous history of cryoglobulinemia
  • EC 11 History of blood clotting or bleeding disease
  • EC 12 Peripheral vascular disease that precludes LV access
  • EC 13 Contraindication to heparin
  • EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure
  • EC 15 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.
  • EC 16 Pregnant, or anticipated pregnancy during study follow-up
  • EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
  • EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)

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: VT Cryoablation
all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT
Enhed: Ultra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Safety Endpoint
Tidsramme: 7 days following the ablation procedure

Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.

Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation • Access site complications requiring medical or surgical intervention • Pericarditis • Heart block requiring a permanent pacemaker • Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
7 days following the ablation procedure
Primary Efficacy Endpoint
Tidsramme: 6 months after the procedure
Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for > 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
6 months after the procedure
Primary Procedural Endpoint
Tidsramme: at the end of the ablation procedure
Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure
at the end of the ablation procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary Safety Endpoint
Tidsramme: 12-months post ablation procedure
Secondary Safety Endpoint is defined as freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the cryoablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC).
12-months post ablation procedure
Secondary Efficacy Endpoint
Tidsramme: 12-months post ablation procedure
Secondary Efficacy Endpoint is defined as freedom from Ventricular Tachycardia lasting longer than 30 seconds or appropriate ICD intervention at 12 months
12-months post ablation procedure

Samarbejdspartnere og efterforskere

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

Sponsor

Adagio Medical

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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CS-300 Rev.H

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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Kliniske forsøg med Ventrikulær takykardi, monomorf

Kliniske forsøg med Ultra Low Temperature Ablation (ULTA)

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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