Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
2026년 5월 18일 업데이트: Aakriti Gupta, Cedars-Sinai Medical Center
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:
- Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
- Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
- Assess patient-reported recovery and quality of life outcomes using validated tools.
The study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.
연구 개요
상태
모병
정황
상세 설명
This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.
연구 유형
관찰
등록 (추정된)
60
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Aakriti Gupta, M.D.
- 전화번호: 267-442-8776
- 이메일: aakriti.gupta@cshs.org
연구 장소
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California
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Los Angeles, California, 미국, 90048
- 모병
- Smidt Heart Institute, Cedars Sinai Medical Center
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연락하다:
- Aakriti Gupta, M.D.
- 전화번호: 267-442-8776
- 이메일: aakriti.gupta@cshs.org
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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
샘플링 방법
비확률 샘플
연구 인구
The study population includes adult patients with severe degenerative mitral regurgitation (DMR) who underwent either surgical mitral valve repair or transcatheter edge-to-edge repair (TEER).
설명
Inclusion Criteria:
- Patients older than 60 years who have DMR will be included in the study
Exclusion Criteria:
- Patients with prior history of mitral intervention or surgery will be excluded.
- Patient records flagged "break the glass" or "research opt out" will be excluded.
- Persons with allergy to animal dander or animal-instigated asthma will be excluded.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Surgical mitral repair
This cohort includes patients who underwent surgical mitral valve repair for severe degenerative mitral regurgitation (DMR).
The intervention involves standard surgical techniques to repair the mitral valve, aiming to restore its physiological function and reduce mitral regurgitation.
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Transcatheter mitral edge-to-edge repair
This cohort includes patients who underwent transcatheter edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR).
The intervention involves a minimally invasive transcatheter procedure using a device to approximate the mitral valve leaflets, reducing regurgitation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
기간: From procedure to 3 years after procedure
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
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From procedure to 3 years after procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
기간: At 30 days, 6 months, and 1 year after procedure
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Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Left Ventricular Ejection Fraction by Transthoracic Echocardiography
기간: At 30 days, 6 months, and 1 year after procedure
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Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Mean Mitral Valve Gradient by Transthoracic Echocardiography
기간: At 30 days, 6 months, and 1 year after procedure
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Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Kansas City Cardiomyopathy Questionnaire Overall Summary Score
기간: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair.
Higher scores indicate better health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Six-Minute Walk Test Distance
기간: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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SF-36 Physical Component Summary Score
기간: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status.
Scores are reported as scale scores, with higher scores indicating better physical health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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SF-36 Mental Component Summary Score
기간: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status.
Higher scores indicate better mental health status.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of Participants With All-Cause Mortality
기간: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of Participants With Heart Failure Hospitalization
기간: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Mitral Valve Reintervention
기간: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
기간: From start of procedure to 30 days after procedure
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Percentage of participants with one or more major periprocedural or 30-day complications after surgical mitral valve repair or transcatheter edge-to-edge repair.
Major complications include coronary obstruction, cardiac tamponade, new left bundle branch block, major bleeding, stroke or transient ischemic attack, myocardial infarction, acute kidney injury, new-onset atrial fibrillation, infection or sepsis, permanent pacemaker implantation, or conversion to open surgery.
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From start of procedure to 30 days after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
기간: From baseline CMR to 6 months after procedure
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Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular ejection fraction, measured as percentage by transthoracic echocardiography at 6 months after procedure.
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From baseline CMR to 6 months after procedure
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Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
기간: From baseline CMR to 6 months after procedure
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Difference in 6-month left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, between participants with and without baseline late gadolinium enhancement on cardiovascular magnetic resonance imaging.
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From baseline CMR to 6 months after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
기간: From baseline CMR to 6 months after procedure
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Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular end-systolic volume index, measured in mL/m² by cardiovascular magnetic resonance imaging at 6 months after procedure.
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From baseline CMR to 6 months after procedure
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2025년 2월 19일
기본 완료 (추정된)
2027년 8월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2026년 3월 16일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00003584
- 1R56HL175516-01 (미국 NIH 보조금/계약)
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미정
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아니
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아니
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