Clin2
NCT07037446Possibly a fitEnrolling by invitation

Occlutech leak device for mitral or aortic paravalvular leaks

Paravalvular Leak

Part of Brain & nervous system, Genetic & congenital, Heart & circulation clinical trials.

This registry tracks the safety and effectiveness of a device designed to close leaks around heart valves (mitral or aortic). It may be an option for people who have significant symptoms like heart failure or anemia from these leaks and are not good candidates for surgery.

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

Phase
N/A
Enrollment
200 people
Ages
18 years and older
Study type
Observational

Who can take part

  • You must be 18 years or older.
  • You have a leak around a mitral or aortic heart valve that causes serious symptoms like severe heart failure or low red blood cells that need transfusions.
  • A surgeon has determined that traditional open-heart surgery is too risky for you, or you are being offered this device as a less invasive option.
  • You are willing to attend follow-up visits and can provide written consent.
  • You are not ineligible for the device due to factors like active infection, allergies to nickel or titanium, need for blood thinners you cannot take, or recent heart attack or surgery.

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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