Clin2
NCT03142152Possibly a fitRecruiting

Mitral valve implant for heart failure with leaky mitral valve

Functional Mitral RegurgitationHeart FailureMitral Valve InsufficiencyHeart DiseasesCardiovascular DiseasesHeart Valve Diseases

Part of Heart & circulation clinical trials.

This trial tests whether a device called the Carillon Mitral Contour System can help people with heart failure caused by a mild-to-moderate leaky mitral valve. You’d be compared against a control group, and the goal is to improve heart failure symptoms and outcomes.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
300 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have heart failure symptoms from a leaky mitral valve that is mild (at least 1+).
  • Your heart failure is in NYHA stages II, III, or IV (the common symptom categories your cardiologist uses).
  • You can walk at least 100 meters but not more than 600 meters in six minutes.
  • Your heart pumping strength (ejection fraction) is 50% or less, and your heart size measures fit the trial’s limits.
  • You recently had high NT-proBNP (a heart-stress blood test) and/or were hospitalized for heart failure or needed stronger heart failure medicines in the past year.
  • You must not have prior valve repair devices or certain valve problems, severe valve calcification, severe other valve disease (like severe aortic stenosis), or likely need heart surgery soon.
  • You must be 18 or older, be able to get the device sized/placed as instructed, and agree to long-term follow-up visits (including possible randomization to control).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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