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Can a new heart valve restore quality of life?

NCT ID NCT07798713

Knowledge-focused Sponsor: Aalborg University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study follows 200 adults in Western Denmark who are having a transcatheter aortic valve implantation, a procedure to replace a narrowed heart valve. Researchers will measure quality of life before the procedure and at follow-up using a standard questionnaire. They will also check heart function and symptoms to see if improvements in these measures match how patients feel. The goal is to better understand the link between objective heart improvements and patients' perceived well-being after TAVI.

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 implantation (TAVI), a procedure to replace a narrowed heart valve without open-heart surgery
What this could lead to
If it works, this could help doctors better predict which patients will feel better after TAVI and improve care for people with aortic stenosis.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not apply to all patients, and quality of life can be affected by many factors beyond the procedure.

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 200 people

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

Started

Aug 2026

Expected to finish

Jan 2029

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

The study population consists of adult patients undergoing transcatheter aortic valve implantation in Western Denmark. Patients will be included prospectively and followed from baseline assessment before TAVI to clinical follow-up after the procedure. Patient-reported health status will be assessed using the Kansas City Cardiomyopathy Questionnaire and combined with clinical, echocardiographic, anatomical, and procedural data obtained from patient records.

Ages

18 years and older

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: * Age ≥18 years * Undergoing transcatheter aortic valve implantation (TAVI) * TAVI performed within the study recruitment period * Available baseline KCCQ assessment * Able to participate in follow-up assessment Exclusion Criteria: * Severe cognitive impairment preventing completion of the KCCQ * Language barrier preventing completion of the KCCQ * Severe illness or clinical condition preventing participation in follow-up

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Conditions

The condition(s) this trial relates to.

Angina Pectoris aortic valve stenosis heart failure intermediate coronary syndrome

As listed by the trial registrant

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

Angina pectoris Aortic stenosis Heart failure Tavi(transcatheter aortic valve implantation)

Contacts and locations

Locations

  • Department of Cardiology Aalborg University Hospital

    Gistrup, 9260, Denmark

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