The study is part of the PRIMARY trial, which explores two ways to fix a heart valve problem, called mitral valve repair (MVr) and transcatheter-edge-to-edge-repair (TEER). This helps learn how a floppy valve can affect the heart's pumping ability and lead to issues like irregular heartbeats or sudden death. By studying this, doctors hope to find better ways to treat heart problems.
In this study, up to 250 people will join from the main trial. Participants will have their heart rhythm monitored, and most will have special heart scans before and after the valve fix. Some will also donate small heart tissue samples during surgery. The study takes place in several countries, including the U.S., Canada, and Germany, over 12-18 months. Results will be tracked for a year.
- Study includes heart scans and rhythm monitoring, with some tissue samples.
- Conducted in the U.S., Canada, Germany, the U.K., and Spain.
- Estimated to last 12-18 months with a year of follow-up.