Gastro-oesophageal Reflux Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are 21 years of age or older
- People who have been diagnosed with severe degenerative mitral regurgitation (a serious heart valve problem where the mitral valve leaks significantly), confirmed by an ultrasound of the heart
- People whose mitral valve leaflets (the flaps of the valve) have a shape and structure that may allow them to be brought together to reduce the leaking without placing too much strain on the valve tissue
- People who are able to give informed consent and are willing to follow the study procedures and attend follow-up appointments
Who may not be able to join:
- People whose mitral valve leaking is caused by a problem with heart function rather than the valve structure itself (known as functional mitral regurgitation)
- People who have heavy calcium deposits on the mitral valve or surrounding tissue
- People who have other significant heart valve problems, such as severe narrowing or leaking of the aortic valve, or severe leaking of the tricuspid valve
- People whose heart's main pumping chamber is working at less than 30% of normal capacity, or who have severe weakness of the right side of the heart
- People who need another heart surgery performed at the same time
- People who have previously had a heart valve procedure or a structural heart procedure (note: prior procedures to open blocked heart arteries may not apply — confirm with trial site)
- People who have had a stroke or heart attack within the past 30 days
- People who are in a state of cardiovascular instability or shock at the time of enrollment
- People who have serious other health conditions that may increase the risks of the procedure, such as advanced liver disease, severe blood disorders, or an active infection
- People who have medical reasons they cannot undergo the required study procedures or take the required medications, including those who cannot tolerate blood thinners or a specialised heart ultrasound performed through the throat
- People who are pregnant, breastfeeding, or planning to become pregnant during the study period
- People who are already participating in another study involving an investigational device or drug that could affect the results
- People who are not expected to live beyond 12 months, or who have any condition that, in the opinion of the treating investigator, makes participation unsuitable
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: James Gammie, MD, Johns Hopkins University
Phone: 443.927.3984
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Primary Safety Endpoint: Composite Freedom from Major Adverse Events; Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.