Transventricular Off-pump Mitral Valve Repair (TRANSOM)
2026년 7월 20일 업데이트: Johns Hopkins University
Transventricular Off-pump Mitral Valve Repair (TRANSOM)
The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet.
This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve.
This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.
연구 개요
상세 설명
The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.
연구 유형
중재적
등록 (추정된)
175
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Lisa Fornaresio, PhD
- 전화번호: 443.927.3984
- 이메일: lisa.fornaresio@jhmi.edu
연구 연락처 백업
- 이름: Rachael Quinn, PhD
- 전화번호: 410.955.2800
- 이메일: rquinn17@jhmi.edu
연구 장소
-
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Maryland
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Baltimore, Maryland, 미국, 21287
- 모병
- Johns Hopkins Hospital
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연락하다:
- Lisa Fornaresio, PhD
- 전화번호: 443-927-3984
- 이메일: lisa.fornaresio@jhmi.edu
-
연락하다:
- Rachael Quinn, PhD
- 전화번호: 410.955.2800
- 이메일: rquinn17@jhmi.edu
-
수석 연구원:
- James S. Gammie, MD
-
-
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:
- Age 21 years or older.
- Presence of severe degenerative mitral regurgitation confirmed by echocardiography.
- Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.
- Ability to provide informed consent and willingness to comply with study procedures and follow-up.
Exclusion Criteria:
- Functional mitral regurgitation.
- Severe mitral annular or leaflet calcification.
- Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).
- Left ventricular ejection fraction <30% or severe right ventricular dysfunction.
- Requirement for concomitant cardiac surgery.
- Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
- Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
- Hemodynamic instability or cardiogenic shock at the time of enrollment.
- Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
- Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
- Pregnancy, lactation, or planned pregnancy during the study period.
- Participation in another investigational device or drug study that could interfere with outcomes.
- Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.
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 |
|---|---|
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실험적: Transventricular off-pump mitral valve repair
Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.
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TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Safety Endpoint: Composite Freedom from Major Adverse Events
기간: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation.
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30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
기간: 1 year post-index procedure.
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Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
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1 year post-index procedure.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Technical Success
기간: Exit from operating room and up to 30 days post-procedure.
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Technical success is defined as patient survival to exit from the operating room, successful implantation of at least three ePTFE cords, and absence of procedure-related emergency surgery or reintervention.
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Exit from operating room and up to 30 days post-procedure.
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Procedural Success
기간: Exit from operating room and up to 30 days post-procedure.
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Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
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Exit from operating room and up to 30 days post-procedure.
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Patient Success
기간: 1 year post-index procedure.
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Defined as procedural success with patient return to the pre-procedural living setting, absence of rehospitalization or reintervention for mitral regurgitation, and appropriate improvement or stability in New York Heart Association (NYHA) functional class.
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1 year post-index procedure.
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Blood Product Usage
기간: Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
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Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Procedure Time
기간: During the index procedure.
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Time from first incision to incision closure (hours).
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During the index procedure.
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Operating Room Time
기간: During the index procedure.
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Time from entry into the operating room suite until exit from the operating room suite (hours).
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During the index procedure.
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Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
기간: During the index procedure.
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Percentage of subjects receiving mitral valve replacement during the index procedure.
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During the index procedure.
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Composite Effectiveness Endpoint
기간: 1 year post-index procedure.
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Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
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1 year post-index procedure.
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Discharged to Home vs Other Facility
기간: At hospital discharge (an average of 4 days following the index procedure).
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Discharge disposition following hospitalization, including discharge to home versus another facility.
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At hospital discharge (an average of 4 days following the index procedure).
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New York Heart Association (NYHA) Functional Class
기간: Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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New York Heart Association functional class (Class I-IV), where Class I indicates no limitation of physical activity and Class IV indicates symptoms at rest; higher class indicates worse functional status.
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Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Regurgitation Grade
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram.
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Ventricular End Diastolic Diameter (LVEDD)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Ventricular End Systolic Diameter (LVESD)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Ventricular End Diastolic Volume (LVEDV)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mL).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Ventricular End Systolic Volume (LVESV)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mL).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Ventricular Ejection Fraction (LVEF)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (%).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Left Atrial Volume
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mL).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Annular Septal-Lateral Dimension
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Right Ventricular Systolic Pressure (RVSP)
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mmHg).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Valve Peak Gradient
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mmHg).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Valve Mean Gradient
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram (mmHg).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Tricuspid Valve Regurgitation (TVR) Grade
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram.
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Right Ventricular Function
기간: Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Measured by transthoracic echocardiogram using tricuspid annular plane systolic excursion (TAPSE) and global assessment of right ventricular function (normal, mild dysfunction, moderate dysfunction, or severe dysfunction).
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Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
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Ventilation Duration
기간: At extubation (an average of 2 hours following the index procedure).
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Total ventilation duration following the index procedure (hours).
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At extubation (an average of 2 hours following the index procedure).
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Intensive Care Unit Length of Stay
기간: At ICU discharge (an average of 1 day following the index procedure).
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Total intensive care unit length of stay following the index procedure (hours).
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At ICU discharge (an average of 1 day following the index procedure).
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Hospital Length of Stay
기간: At hospital discharge (an average of 4 days following the index procedure).
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Total hospital length of stay following the index procedure (days).
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At hospital discharge (an average of 4 days following the index procedure).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: James Gammie, MD, Johns Hopkins University
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 (실제)
2026년 6월 8일
기본 완료 (추정된)
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2029년 7월 1일
연구 등록 날짜
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2026년 7월 6일
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처음 게시됨 (실제)
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추가 정보
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