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

2026년 6월 11일 업데이트: 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)

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: VT Cryoablation
all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT
장치: Ultra Low Temperature Ablation (ULTA)
ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Safety Endpoint
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Secondary Safety Endpoint
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Adagio Medical

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 3월 31일

연구 완료 (추정된)

2027년 9월 30일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CS-300 Rev.H

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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