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

11 giugno 2026 aggiornato da: 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)

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: VT Cryoablation
all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT
Dispositivo: Ultra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Primary Safety Endpoint
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Secondary Safety Endpoint
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Adagio Medical

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

30 settembre 2027

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CS-300 Rev.H

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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