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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (13 UK sites)
Royal Papworth Hospital NHS Foundation Trust
Cambridge CB2 0AY, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds LS1 3EX, United Kingdom
St. Thomas Guy's and St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust
London SW3 6NP, United Kingdom
Manchester University NHS Foundation Trust
Manchester M23 9LT, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing BN2 5BE, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2TH, United Kingdom
University Hospital Bristol and Weston NHS Foundation Trust
Bristol BS1 3NU, United Kingdom
Golden Jubilee University National Hospital
Clydebank G81 4DY, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Headington OX3 9DU, United Kingdom
Barts Health NHS Trust
London E1 8PR, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough TS4 3BW, United Kingdom
