Percutaneous or surgical repair in mitral prolapse and regurgitation for 65 year-olds and over (PRIMARY).
What?
Mitral valve regurgitation (known as MR) is a condition where the mitral valve in the heart does not close fully when it is supposed to, and some blood can then leak back into the heart instead of being pumped around the rest of the body.
MR makes the heart have to work harder than usual and can make patients feel tired and short of breath.
There are two ways to treat MR:
- TEER (Transcatheter edge-to-edge repair) is a procedure involving using a thin tube (a catheter) guided through a vein in your leg to reach your heart and attaching a clip to your mitral valve to help it close properly. This procedure does not involve accessing your heart surgically.
- Mitral valve surgical repair is a procedure which accesses the heart directly to repair the valve.
Both treatments are well established and both are regularly used to treat MR.
The aim of the PRIMARY trial is to compare the long term risks and benefits of the two different procedures used to help patients with MR.
How?
Internationally, 450 eligible and consenting patients with mitral valve regurgitation will be split into two groups.
One group will receive TEER and one group will receive surgical repair.
Both groups will be followed up for five years after their treatment and their data will be analysed to compare the effectiveness of both treatments.
In the UK, we are looking for 100 patients to take part in the trial.
ClinicalTrials.gov Identifier: NCT05051033
US Chief investigators
Annetine Gelijns, PhD, Alan Moskowitz, MD, Joanna Chikwe, MD.
Funder
National Heart, Lung, and Blood Institute (NHLBI)
UK Chief investigator
Professor Enoch Akowuah
UK recruiting sites
- South Tees Hospitals NHS Foundation Trust
- Leeds Teaching Hospitals NHS Foundation Trust
- University Hospitals Sussex NHS Foundation Trust
- Royal Papworth Hospitals NHS Foundation Trust
- King’s College Hospital NHS Foundation Trust