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Heart valve study seeks hidden clues in rare amyloidosis link

NCT ID NCT07170306

Knowledge-focused Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will observe 143 older adults with severe aortic stenosis who are scheduled for a minimally invasive valve replacement procedure called TAVR. Researchers want to find out how many also have cardiac amyloidosis, a condition where abnormal proteins build up in the heart. They will compare health outcomes and track changes in blood markers over 12 months to better understand the link between these two heart conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcatheter aortic valve replacement (TAVR)
What this could lead to
If successful, this could help doctors better identify and treat patients with both aortic stenosis and cardiac amyloidosis, potentially improving survival and quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not apply to all patients, and TAVR carries standard procedural risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 143 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients admitted to the Cardiology Ward who undergo transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) from May 2025 to May 2028.

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients aged ≥ 65 years and ≤ 85 years; * Patients with moderate-to-severe degenerative aortic stenosis (AS) who are hospitalized and scheduled to undergo transcatheter aortic valve replacement (TAVR); * Patients who voluntarily sign the Informed Consent Form (ICF) and are able to comply with the study-specified treatment plan, follow-up visits, laboratory tests, and other requirements. Exclusion Criteria: * Aortic stenosis (AS) caused by congenital diseases or rheumatic immune diseases; * Severe renal impairment, chronic dialysis, or unresolved acute kidney injury after transcatheter aortic valve replacement (TAVR); * Terminal-stage diseases with an expected life span of \< 6 months; * Participation in other ongoing investigational studies of drugs or medical devices that have not yet been completed; * Patients who are unable to attend the follow-up visits scheduled in the study; * Failure to undergo TAVR surgery, transfer to surgical treatment, or in-hospital death.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Transthyretin amyloid cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.