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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices

2026년 9월 17일 업데이트: National Heart, Lung, and Blood Institute (NHLBI)

This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.

Excessively-thick heart muscle can cause serious heart disease, especially heart failure with preserved ejection fraction, which causes shortness of breath and heart failure symptoms such as edema (swelling) and pulmonary congestion (lung water). Specific circumstances of excessively-thick heart muscle can block outflow of blood from the main heart pumping chamber (left ventricle).

We developed a catheter technique called SESAME (SEptal Scoring Along Midline Endocardium) to slice the excessively-thick heart muscle causing such problems. SESAME can be used in patients who have symptoms related to excessively-thick heart muscle in a part of the heart that restricts blood ejection from the heart; the problem is called "left ventricular outflow tract obstruction (LVOTO)." One group of patients who might benefit from SESAME suffer from a common inherited heart muscle disease called "hypertrophic cardiomyopathy (HCM)." Patients with HCM and symptoms from LVOTO can be treated with medications, open heart surgery, or catheter-based destruction of heart muscle in "alcohol septal ablation." If these treatments fail or are not suitable, then SESAME may be an option, because it resembles surgery treatment without open heart surgery.

Other groups of patients that might benefit are those with heart valve diseases, of the mitral or of the aortic valve, or both, along with excessively-thick heart muscle. These patients may be poor candidates for standard surgical valve repair or replacement because of high risk of complications or death. Such patients might be eligible for non-surgical transcatheter mitral valve replacement, either standard or unapproved ("off-label") or research ("investigational"), but are poor candidates because of risk of LVOTO. Moreover, about half have LVOTO making heart valve symptoms worse. Treating the LVOTO alone may improve symptoms enough that heart valve treatment can be delayed or avoided.

This is a sponsor-investigator IDE study of SESAME performed at a small number of centers that have adopted the technique in the practice of medicine, in order better to characterize how well it works and whether it is safe.

Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.

The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Cardiac septal reduction therapies - to relieve left ventricular outflow tract obstruction from transcatheter mitral valve replacement or hypertrophic cardiomyopathy - have inherent limitations including dependence on coronary anatomy, high pacemaker implantation rate, and surgical morbidity. We developed a novel transcatheter ventricular myotomy called SEptal Scoring Along the Midline Endocardium (SESAME) that relies on intramyocardial guidewire navigation and transcatheter electrosurgery. SESAME has been performed on hundreds of patients worldwide using improvised (off-label and bedside-modified commercially available) devices. Recent benchtop refinements in SESAME technique, using improvised devices, are predicted to reduce the likelihood of serious complications such as ventricular perforation, iatrogenic ventricular septal defect, and death.

This sponsor-investigator IDE study systematically characterizes the safety and outcomes of SESAME at up to 10 enrolling sites. SESAME is performed as septal reduction therapy in a heterogeneous group of participants, including (1) symptomatic hypertrophic cardiomyopathy with resting or provoked left ventricular outflow obstruction (LVOTO); and (2) severe symptomatic mitral valve disease at high risk of standard heart surgical therapy and requiring later transcatheter mitral valve implantation combined with manifest or potential LVOTO. This study attempts to capture generalizable knowledge from as many patients as possible who undergo SESAME, and to add a limited number of research procedures to characterize the safety and provisional effectiveness of SESAME.

Participating centers already perform SESAME in the practice of medicine using improvised, off-label devices. This protocol allows prospective oversight, standardized technique constraints, central imaging review, independent monitoring, and formal safety adjudication. In addition, the investigational protocol does not function as the gatekeeper for access to SESAME.

The investigators are not affiliated with the guidewire manufacturer and do not seek marketing approval or clearance for SESAME.

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20010
        • MedStar Washington Hospital Center
        • 연락하다:
          • Toby Rogers, M.D.
          • 전화번호: 202-877-5975
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Emory University Hospital
        • 연락하다:
          • Vasilis Babaliaros, M.D.
          • 전화번호: 678-557-4514
        • 연락하다:
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Medical Center
        • 연락하다:
          • James McCabe, M.D.
          • 전화번호: 617-667-8800
    • New York
      • Roslyn, New York, 미국, 11576
        • St. Francis Hospital & Heart Center
        • 연락하다:
          • Jaffar M Khan, M.D.
          • 전화번호: 516-390-9640
      • The Bronx, New York, 미국, 10461
        • Montefiore Medical Center: Einstein Campus
        • 연락하다:
          • Mohamed Azeem Latib, M.D.
          • 전화번호: 718-920-4212
    • Pennsylvania
      • York, Pennsylvania, 미국, 17403
        • WellSpan York Hospital
        • 연락하다:
          • Christopher G Bruce, M.D.
          • 전화번호: 717-851-2441
    • Virginia
      • Charlottesville, Virginia, 미국, 22908
        • Univ. of Virginia
        • 연락하다:
          • John Saxon, M.D.
          • 전화번호: 434-243-1000
      • Roanoke, Virginia, 미국, 24014
        • Carilion Roanoke Memorial Hospital
        • 연락하다:

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
  • Adults age >= 21 years

  • Requires left ventricular septal reduction therapy for one of two indications

    1. Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR
    2. Planned transcatheter mitral valve replacement is feasible but limited by risk for iatrogenic left ventricular outflow tract obstruction, defined on contrast-enhanced CT as skirt-neo-LVOT <200^2
  • Planning to undergo SESAME transcatheter myotomy

  • Septal diastolic thickness on CT as measured by the NHLBI central laboratory before enrollment:

    • For obstructive hypertrophic cardiomyopathy, >=14mm;
    • For transcatheter heart valve replacement, >=12mm

and

  • Intended minimum diastolic residual septal thickness >=6mm

    -Severely symptomatic, any of

  • NYHA Class III or greater

  • Canadian Angina Class CCS III or greater

    • Explicitly chooses investigational SESAME over conventional treatment approaches including

      1. cardiac myosin inhibitor therapy, if eligible (obstructive HCM only);
      2. transcoronary alcohol septal ablation, if eligible; or
      3. surgical left ventricular myotomy and/or myectomy, if eligible
    • Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy and that SESAME is an appropriate septal reduction strategy for this candidate.
    • Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing

EXCLUSION CRITERIA

  • Does not consent to participate, or unable to consent to participate
  • Pregnant
  • Hemodynamic instability or emergency procedure
  • Mechanical aortic valve
  • eGFR < 30 mL/min/1.73m^2

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SESAME Arm
The intervention is the SESAME procedure.
장치: SESAME Procedure
The intervention is the SESAME procedure, a catheter-based septal myotomy performed in adults with symptomatic or high-risk LVOT obstruction. It uses off-label Astato XS 20/40 guidewires and the NHLBI LCI electrosurgery timing appliance to create a controlled longitudinal laceration through the hypertrophied interventricular septum under fluoroscopic and echocardiographic guidance, with energy delivery limited to short pulses and cooling intervals to reduce thermal injury; all participants receive the same procedure, with follow-up assessments afterward.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
SESAME Technical Success
기간: Completion of SESAME procedure
The primary outcome is technical success, defined as the participant being alive and having a successful SESAME laceration, with post-procedure CT showing that the achieved minimum residual septal thickness matches the planned thickness within 20%.
Completion of SESAME procedure
SESAME Safety
기간: 30 days after SESAME procedure
The primary safety endpoint is freedom at 30 days from all-cause mortality, any stroke (disabling or non-disabling), and major SESAME-related cardiac structural complications requiring intervention, such as iatrogenic ventricular septal defect, aortic or mitral regurgitation, tamponade, or new permanent pacemaker implantation.
30 days after SESAME procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Heart, Lung, and Blood Institute (NHLBI)

수사관

  • 수석 연구원: Robert J Lederman, M.D., National Heart, Lung, and Blood Institute (NHLBI)

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 9월 23일

기본 완료 (추정된)

2029년 3월 1일

연구 완료 (추정된)

2030년 3월 1일

연구 등록 날짜

최초 제출

2026년 9월 3일

QC 기준을 충족하는 최초 제출

2026년 9월 4일

처음 게시됨 (실제)

2026년 9월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 11일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 10002783
  • 002783-H

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. .

구독하다