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经皮或手术二尖瓣修复术 (PRIMARY)

2026年10月23日 更新者：Annetine Gelijns

≥ 65 岁的二尖瓣脱垂和反流的经皮或手术修复（初级）

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

450

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Surgical mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery.
程序：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.

其他名称：
  • 二尖瓣手术
有源比较器：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.
设备：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.

其他名称：
  • 特尔

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Adequacy of MR correction
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：5 years post randomization

All-cause mortality through 5 years post randomization
5 years post randomization
All-cause mortality
大体时间：10 years post intervention

All-cause mortality from randomization through 10 years post intervention
10 years post intervention
Cardiovascular and non-cardiovascular mortality
大体时间：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
大体时间：10 years post intervention

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

Valve re-interventions through 5 years post intervention
5 years post intervention
Valve re-interventions
大体时间：10 years post intervention

Valve re-interventions through 10 years post intervention
10 years post intervention
Serious or protocol-defined adverse events
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：through 10 years post intervention

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Annetine Gelijns

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 研究主任：Martin Leon, MD、Columbia University
  • 研究主任：Patrick O'Gara, MD、Brigham and Women's Hospital
  • 研究主任：Joanna Chikwe, MD、Cedars Sinai

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年2月21日

初级完成 (估计的)

2029年6月30日

研究完成 (估计的)

2034年1月31日

研究注册日期

首次提交

2021年9月10日

首先提交符合 QC 标准的

2021年9月10日

首次发布 (实际的)

2021年9月21日

研究记录更新

最后更新发布 (实际的)

2026年10月27日

上次提交的符合 QC 标准的更新

2026年10月23日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY-21-01246
  • 5U01HL088942 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

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 共享访问标准

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

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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