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ACTIVE NOT RECRUITINGNA

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Sponsor: Annetine Gelijns

NCT ID: NCT05051033

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Mitral valve repair (procedure), Transcatheter edge-to-edge repair (device)
How long the study runs
Study runs about 143 months (dates as stated)
About the drug or intervention
Mitral valve repair — procedure: Patients who are randomized to the surgical arm will undergo mitral surgery. · Transcatheter edge-to-edge repair — device: Patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
60 Years and over
Who
All
Number of participants
450
Started
2022-02-21
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for mitral valve regurgitation
  • • NA - 450 participants
  • • 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)

Who can take part?

  • • Ages 60 Years and over
  • • Diagnosed with mitral valve regurgitation

Where?

  • • Cambridge - Royal Papworth Hospital NHS Foundation Trust
  • • Leeds - The Leeds Teaching Hospitals NHS Trust
  • • London - St. Thomas Guy's and St Thomas' NHS Foundation Trust
  • • London - King's College Hospital NHS Foundation Trust
  • • +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Mitral Valve Regurgitation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 60 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR...
  • ✓Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

Who cannot take part

  • ✗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
See the full criteria
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.

Where Is This Study? (13 UK sites)

Royal Papworth Hospital NHS Foundation Trust

Cambridge CB2 0AY, United Kingdom

Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

The Leeds Teaching Hospitals NHS Trust

Leeds LS1 3EX, United Kingdom

Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

St. Thomas Guy's and St Thomas' NHS Foundation Trust

London SE1 7EH, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust

London SW3 6NP, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Manchester University NHS Foundation Trust

Manchester M23 9LT, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

University Hospitals Sussex NHS Foundation Trust

Worthing BN2 5BE, United Kingdom

Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

University Hospital Bristol and Weston NHS Foundation Trust

Bristol BS1 3NU, United Kingdom

Hospital R&D contact (matched)

Diana Benton

research@uhbw.nhs.uk0117 342 0233

Golden Jubilee University National Hospital

Clydebank G81 4DY, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Headington OX3 9DU, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Barts Health NHS Trust

London E1 8PR, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

South Tees Hospitals NHS Foundation Trust

Middlesbrough TS4 3BW, United Kingdom

Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089
Data sourced from ClinicalTrials.gov · Last verified: 2026-09