Gastro-oesophageal Reflux Disease Trial, Recruiting NCT05496998 Sponsor: Medtronic Cardiovascular Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT05496998
Recruiting Not Applicable

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:

  • You have a moderate-to-severe or severe leaky mitral heart valve (called mitral regurgitation) that is causing symptoms, OR you have a moderately leaky mitral valve combined with a narrowed mitral valve, along with calcium buildup around the valve
  • A specialist heart team at the trial site has reviewed your case and agreed that standard surgery or approved catheter-based repair treatments are not suitable for you
  • You are willing and able to return for all required follow-up appointments after the procedure
  • You meet the minimum legal age required to give consent in your country
  • The shape and structure of your heart is suitable for the specific device being tested in this trial (the Medtronic Intrepid™ system)

Who may not be able to join:

  • Your life expectancy is estimated to be less than 24 months
  • You already have a surgically implanted artificial mitral valve
  • You have previously had a catheter-based mitral valve procedure and that device is still in place
  • Your heart anatomy is not compatible with the procedure (confirm with trial site)
  • You have severe calcium buildup around the mitral valve that makes the procedure impossible
  • You have aortic valve disease that needs treatment, or you had aortic valve treatment within the last 90 days
  • Your heart pumping strength (ejection fraction) is below 25%; if it is between 25–30%, a review committee will assess whether you can still participate
  • The lower left chamber of your heart is enlarged beyond a certain size
  • You need emergency or urgent heart surgery
  • Your heart is not pumping well enough to keep your body stable (confirm with trial site)
  • You have a history of serious bleeding problems or a condition where your blood does not clot properly
  • You have advanced kidney disease requiring dialysis or similar treatment
  • You have liver failure
  • You have been assessed as significantly frail

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Thomas Modine, Prof., University Hospital, Bordeaux

Phone: +31 (0)43 356 6566

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

Status
Recruiting
Phase
Not Applicable
Sponsor
Medtronic Cardiovascular
Registry
ClinicalTrials.gov
Start date
7 February 2023
Est. completion
1 August 2029

Where this trial is recruiting

🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom

Primary endpoints

Safety: all-cause mortality at 1-year post-procedure.; Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov