PRIMARY
Research type
Research Study
Full title
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)
IRAS ID
318625
Contact name
Enoch Akowuah
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 1 months, 27 days
Research summary
The mitral valve is one of four valves in the heart. Its role is to stop blood flowing the wrong way through the heart. Mitral valve regurgitation (known as MR) is a condition where the valve does not close fully when it is supposed to and allows some blood to leak and flow the wrong way. People with MR (valve leakage) may experience dizziness, breathlessness, tiredness and chest pain. If this isn’t treated it can lead to an irregular heartbeat, blood clots or heart failure.
Treatments include:
1. medicines to relieve symptoms;
2. heart surgery to repair or replace the mitral valve - the traditional method to treat this condition;
3. a keyhole procedure, where a small clip is attached to the mitral valve to help it close, the clip is guided into the heart through a thin tube (catheter) inserted into a vein in the groin. This procedure is called transcatheter edge-to-edge repair (TEER).In the UK, TEER is available for adults with symptomatic and severe MR (specifically a type called primary degenerative MR) who are not able to have a full heart operation, or are very high risk for conventional mitral valve surgery, where reduction of MR would benefit the patient.
There are no new or “experimental” procedures being tested in this study: both heart surgery and TEER are well-established and are regularly performed in patients who have MR. However, there is no clear longer-term data comparing whether TEER works and is safe in a wider group of patients.
This research will compare the risks and benefits of heart surgery and TEER in patients aged 65 and over with moderately severe or severe primary degenerative MR who are assessed by their clinical care team as suitable for both types of procedure. Participants will be followed for 5 years.
REC name
Wales REC 5
REC reference
22/WA/0362
Date of REC Opinion
22 Dec 2022
REC opinion
Favourable Opinion