이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

경피적 또는 외과적 승모판 수리 (PRIMARY)

2026년 10월 23일 업데이트: Annetine Gelijns

≥65세의 승모판 탈출증 및 역류의 경피적 또는 외과적 봉합(일차)

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. This study is closely integrated with the PRIMARY Ancillary Substudy (NCT07103733)

The patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.

Because the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE).

Outcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.

연구 유형

중재적

등록 (실제)

450

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 독일
      • Bad Nauheim, 독일, 61231
        • Kerckhoff Klinik Bad Nauheim
      • Bad Rothenfelde, 독일, 49214
        • Schüchtermann-Klinik Bad Rothenfelde
      • Berlin, 독일, 13353
        • Deutsches Herzzentrum der Charité
      • Frankfurt, 독일, 60590
        • Universitätsklinikum Frankfurt
      • Freiburg im Breisgau, 독일, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, 독일, 20099
        • Asklepios Klinik St. Georg Hamburg
      • Hamburg, 독일, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Heidelberg, 독일, 69120
        • Universitätsklinikum Heidelberg
      • Jena, 독일, 07747
        • Universitätsklinikum Jena
      • Kiel, 독일, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Leipzig, 독일, 04289
        • Herzzentrum Leipzig
      • Lübeck, 독일, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • München, 독일, 80636
        • Deutsches Herzzentrum München
    • Berlin-kölnische Allee
      • Cologne, Berlin-kölnische Allee, 독일, 50969
        • Universitätsklinikum Köln
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, 독일, 50937
        • Universitätsklinikum Köln
  • 미국
    • California
      • Los Angeles, California, 미국, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, 미국, 90033
        • Keck Hospital of the University of Southern California
      • San Francisco, California, 미국, 94143
        • University of California San Francisco
      • Stanford, California, 미국, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, 미국, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, 미국, 30322
        • Emory University
      • Atlanta, Georgia, 미국, 30309
        • Piedmont Heart Institute
    • Louisiana
      • New Orleans, Louisiana, 미국, 70121
        • Ochsner Clinic
    • Maine
      • Portland, Maine, 미국, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, 미국, 02115
        • Brigham and Women's
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Hospital
    • Missouri
      • Kansas City, Missouri, 미국, 64111
        • Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Bay Shore, New York, 미국, 11706
        • Northwell - South Shore
      • Manhasset, New York, 미국, 11030
        • Northwell Health - North Shore
      • New York, New York, 미국, 10032
        • New York-Presbyterian/Columbia University Medical Center
      • New York, New York, 미국, 10075
        • Northwell Health - Lenox Hill
      • New York, New York, 미국, 10065
        • Weill Cornell Medicine/ New York-Presbyterian Hospital
      • Staten Island, New York, 미국, 10305
        • Northwell Staten Island University Hospital
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, 미국, 75246
        • Baylor, Scott and White
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • University of Virginia Medical Center
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • West Virginia University Hospital
  • 스페인
      • Barcelona, 스페인, 08036
        • Hospital Clinic De Barcelona
      • Madrid, 스페인, 28040
        • Hospital Clínico San Carlos
      • Oviedo, 스페인, 33011
        • Hospital Central de Asturias
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, 스페인, 07120
        • Hospital Universitari Son Espases.
    • Galacia
      • Vigo, Galacia, 스페인, 36204
        • Hospital Alvaro Cunqueiro
  • 영국
      • Birmingham, 영국, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Bristol, 영국, BS1 3NU
        • University Hospital Bristol and Weston NHS Foundation Trust
      • Clydebank, 영국, G81 4DY
        • Golden Jubilee University National Hospital
      • Headington, 영국, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
      • London, 영국, E1 8PR
        • Barts Health NHS Trust
      • Middlesbrough, 영국, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
    • England
      • Cambridge, England, 영국, CB2 0AY
        • Royal Papworth Hospital NHS Foundation Trust
      • Leeds, England, 영국, LS1 3EX
        • The Leeds Teaching Hospitals NHS Trust
      • London, England, 영국, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, England, 영국, SE1 7EH
        • St. Thomas Guy's and St Thomas' NHS Foundation Trust
      • London, England, 영국, SW3 6NP
        • Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust
      • Manchester, England, 영국, M23 9LT
        • Manchester University NHS Foundation Trust
    • West Sussex
      • Worthing, West Sussex, 영국, BN2 5BE
        • University Hospitals Sussex NHS Foundation Trust
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다, BC V6E 1M7
        • University of British Columbia, Providence Health Care, St. Paul's Hospital
    • Ontario
      • London, Ontario, 캐나다, ON N6A 5W9
        • London Health Sciences
      • Ottawa, Ontario, 캐나다, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, 캐나다, M5B 1W8St
        • Unity Health Toronto (St. Michael's Hospital)
    • Quebec
      • Québec, Quebec, 캐나다, QC G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)

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

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.

Inclusion Criteria:

  • Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography
  • Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification
  • Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease)
  • Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation.
  • Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

Exclusion Criteria:

  • Non-degenerative types of primary MR (e.g., cleft leaflet)
  • Secondary or functional MR
  • Hypertrophic obstructive cardiomyopathy
  • Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment
  • Known allergic reactions to intravenous contrast
  • Febrile illness within 30-days prior to randomization
  • Any absolute contraindication to transesophageal echocardiography
  • Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia
  • Patients with CAD requiring revascularization
  • Any prior mitral valve intervention or any prior repair of atrial septal defect
  • Any prior MV intervention or any prior repair of atrial septal defect
  • Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery
  • Need for any emergency intervention or surgery
  • Active endocarditis
  • Hemodynamic instability defined as cardiac index <2.0 l/min/m2 or systolic blood pressure <90mmHg or need for inotropic support or any mechanical circulatory support
  • Left ventricular ejection fraction <25%
  • Intracardiac mass or thrombus
  • Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely
  • Active substance abuse
  • Suspected inability to adhere to follow-up
  • Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Surgical mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery.
절차: Mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.

다른 이름들:
  • 승모판 수술
활성 비교기: Transcatheter edge-to-edge repair

In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
장치: Transcatheter edge-to-edge repair

Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.

다른 이름들:
  • 티어

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.
기간: 3 years post intervention

All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention.

Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.
3 years post intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Adequacy of MR correction
기간: one year post intervention

Adequacy of MR correction at one year post intervention, defined as < 2+ MR as assessed by TTE
one year post intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ)
기간: up to 10 years post intervention

Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome.
up to 10 years post intervention
Procedure failure
기간: End of procedure

Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
End of procedure
Procedure failure
기간: 10 years post randomization

Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
10 years post randomization
All-cause mortality
기간: 5 years post randomization

All-cause mortality through 5 years post randomization
5 years post randomization
All-cause mortality
기간: 10 years post intervention

All-cause mortality from randomization through 10 years post intervention
10 years post intervention
Cardiovascular and non-cardiovascular mortality
기간: 5 years post intervention

Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention
5 years post intervention
Cardiovascular and non-cardiovascular mortality
기간: 10 years post intervention

Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention
10 years post intervention
Valve re-interventions
기간: 5 years post intervention

Valve re-interventions through 5 years post intervention
5 years post intervention
Valve re-interventions
기간: 10 years post intervention

Valve re-interventions through 10 years post intervention
10 years post intervention
Serious or protocol-defined adverse events
기간: 5 years post intervention

Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years
5 years post intervention
MR grade
기간: up to 6 years post intervention

Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.)
up to 6 years post intervention
Left Ventricular Ejection Fraction (LVEF)
기간: up to 6 years post intervention

Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction.
up to 6 years post intervention
Left Ventricular End Diastolic Dimension (LVEDD)
기간: up to 6 years post intervention

Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
up to 6 years post intervention
Left Ventricular End Systolic Dimension (LVESD)
기간: up to 6 years post intervention

Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
up to 6 years post intervention
Left Ventricular End Diastolic Volume (LVEDV)
기간: up to 6 years post intervention

Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling.
up to 6 years post intervention
Left Ventricular End Systolic Volume (LVESV)
기간: up to 6 years post intervention

Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling.
up to 6 years post intervention
Mitral valve gradient
기간: up to 6 years post intervention

The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder.
up to 6 years post intervention
Forward stroke volume
기간: up to 6 years post intervention

The forward stroke volume is the volume entering the aorta.
up to 6 years post intervention
6 Minute Walk Test (6MWT)
기간: up to 5 years post intervention

Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes
up to 5 years post intervention
EuroQol- 5 Dimension (EQ-5D)
기간: through 10 years post intervention

Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
through 10 years post intervention
Length of stay (LOS)
기간: through 10 years post intervention

Length of stay as measured by number of days hospitalized.
through 10 years post intervention
ICU days of index hospitalization
기간: through 10 years post intervention

Number of ICU days of index hospitalization
through 10 years post intervention
Number and reasons for readmissions
기간: through 10 years post intervention

Number and reasons for readmissions, including for valve re-intervention and readmissions/urgent visits for heart failure
through 10 years post intervention
Cost
기간: through 10 years post intervention

Costs associated with the index hospitalization as well as follow-up readmissions will be measured.
through 10 years post intervention
Cost-effectiveness
기간: through 10 years post intervention

A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines.
through 10 years post intervention
Number of participants with stroke with disability
기간: 30 days post-intervention

Stroke with disability is defined as a modified Rankin score of ≥ 2 and/or major bleeding (BARC Type 3b, 3c and 5) by 30 days post-intervention
30 days post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Annetine Gelijns

협력자

National Heart, Lung, and Blood Institute (NHLBI)

수사관

  • 연구 책임자: Martin Leon, MD, Columbia University
  • 연구 책임자: Patrick O'Gara, MD, Brigham and Women's Hospital
  • 연구 책임자: Joanna Chikwe, MD, Cedars Sinai

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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)

2022년 2월 21일

기본 완료 (추정된)

2029년 6월 30일

연구 완료 (추정된)

2034년 1월 31일

연구 등록 날짜

최초 제출

2021년 9월 10일

QC 기준을 충족하는 최초 제출

2021년 9월 10일

처음 게시됨 (실제)

2021년 9월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 23일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY-21-01246
  • 5U01HL088942 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 공유 기간

De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.

IPD 공유 액세스 기준

Anyone who wishes to access the data. Any purpose. Data are available indefinitely at link included in the URL field below.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

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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