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Simple blood test may predict pacemaker need after heart valve procedure

NCT ID NCT07201363

Knowledge-focused Sponsor: Clinical Hospital Center Rijeka Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is looking at whether certain substances in the blood, related to inflammation and scarring, can predict if a person will develop heart rhythm problems after a procedure called TAVI (transcatheter aortic valve implantation). TAVI is a less invasive way to replace a narrowed heart valve. About 102 people with severe aortic stenosis will have blood samples taken before their TAVI procedure. Researchers will then track who develops new heart rhythm issues or needs a permanent pacemaker, and see if those people had different levels of these blood markers beforehand.

What this could mean

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

What this could lead to
If successful, this could help doctors identify patients at higher risk for heart rhythm problems after TAVI, potentially leading to better monitoring or preventive strategies.
What could go wrong
This is an observational study, not a treatment trial. It is small (102 participants) and only looks at blood markers before the procedure, so results may not apply to all patients or lead to direct changes in care.

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 102 people

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

Started

Dec 2024

Expected to finish

Aug 2026

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 trial will include a minimum 102 consecutive patients with severe AS hospitalized in Clinical Hospital Centre Rijeka for a planned TAVI procedure, according to the previous Heart Team decision.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Written consent to participate in the trial * Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease Exclusion Criteria: * Acute infectious disease * Chronic inflammatory or autoimmune disease * Corticosteroid or other immunosuppressive therapy * Active malignant disease * Liver disease accompanied by dysfunction * Permanent pacemaker implanted previously * An acute myocardial infarction within three months before the procedure * A surgical procedure within three months before the procedure * Previous surgical or transcatheter aortic valve replacement/implantation * End-stage chronic kidney disease (eGFR \<15 ml/min)

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac cardiac conduction defect Fibrosis Inflammation

As listed by the trial registrant

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

Aortic stenosis Conduction disorder Permanent pacemaker implantation Tavi(transcatheter aortic valve implantation)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Clinical Hospital Center Rijeka

    RECRUITING

    Rijeka, Croatia, 51000, Croatia

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