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Donate blood samples to help identify early heart valve problems | stella

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Recruiting

Blood markers to detect heart valve problems after implant surgery

Plain-English translation of NCT04552275 on ClinicalTrials.gov ↗ · Source last updated November 2021 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

Researchers are looking for blood proteins that could help detect a condition called hypo-attenuated leaflet thickening (HALT)—a type of valve problem that sometimes develops after people receive a new artificial heart valve. By studying blood samples from people before and after valve replacement surgery, the team hopes to find a simple blood test that can catch this problem early. If successful, this could help doctors monitor patients more easily and treat any problems faster.

Some patients develop a thickening of their new heart valve after surgery, but doctors currently detect this only through heart imaging scans. This study hopes to find a blood test that could spot the problem earlier and more easily, without needing repeated imaging.

Do you qualify?

You likely qualify if…

you are 65 years old or older
you have severe aortic stenosis (a narrowed heart valve) or a failing previous prosthetic valve
you are scheduled to have a catheter-based heart valve replacement surgery using a Medtronic valve
you are able to return for follow-up visits over 6 months

You likely don't qualify if…

you are already taking blood thinners regularly
you cannot safely take blood thinning medications
you have severe kidney disease
you have a bleeding disorder or blood clotting abnormality
you have a life expectancy of less than 12 months due to another serious illness

What participation looks like

You would have blood drawn before your valve replacement surgery, again before you leave the hospital, and then at follow-up visits around 30 days and 6 months after surgery. If you develop the valve thickening condition, you would receive blood-thinning medication for 5–6 months and have additional blood tests and heart imaging. All participants will provide blood samples and allow researchers to review your heart imaging results.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(3 sites)

United States

Massachusetts General Hospital, Boston, Massachusetts

Minneapolis Heart Institute, Minneapolis, Minnesota

Catholic Medical Center, Manchester, New Hampshire

Key details

Phase

Safety & dosing

Sponsor

Massachusetts General Hospital

Collaborators

Medtronic, Catholic Medical Center

Enrollment target

~300 participants

Started

June 2020

Primary completion

June 2030

Age range

65 Years and older

Last updated on clinicaltrials.gov in November 2021.

Contact the research team directly

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Central contact

Roukoz Abou Karam

Massachusetts General Hospital

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View full record on ClinicalTrials.gov