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経皮的または外科的僧帽弁修復 (PRIMARY)

2026年10月23日 更新者：Annetine Gelijns

65 歳以上の僧帽弁逸脱および逆流における経皮的または外科的修復 (プライマリ)

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

450

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

60年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Surgical mitral valve repair

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

他の名前：
  • 僧帽弁手術
アクティブコンパレータ：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.
デバイス：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.

他の名前：
  • ティア

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Adequacy of MR correction
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：5 years post randomization

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

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

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

Valve re-interventions through 5 years post intervention
5 years post intervention
Valve re-interventions
時間枠：10 years post intervention

Valve re-interventions through 10 years post intervention
10 years post intervention
Serious or protocol-defined adverse events
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：through 10 years post intervention

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Annetine Gelijns

協力者

National Heart, Lung, and Blood Institute (NHLBI)

捜査官

  • スタディディレクター：Martin Leon, MD、Columbia University
  • スタディディレクター：Patrick O'Gara, MD、Brigham and Women's Hospital
  • スタディディレクター：Joanna Chikwe, MD、Cedars Sinai

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年2月21日

一次修了 (推定)

2029年6月30日

研究の完了 (推定)

2034年1月31日

試験登録日

最初に提出

2021年9月10日

QC基準を満たした最初の提出物

2021年9月10日

最初の投稿 (実際)

2021年9月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月27日

QC基準を満たした最後の更新が送信されました

2026年10月23日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY-21-01246
  • 5U01HL088942 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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