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Should you fix a leaky heart valve early? new study seeks answers

NCT ID NCT05438862

Disease control Sponsor: Na Homolce Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether early surgery to repair or replace the aortic valve is better than waiting until symptoms appear in people with severe aortic regurgitation (a leaky heart valve). About 217 adults with no symptoms but severe valve leakage will be randomly assigned to either early surgery or standard watchful waiting. The goal is to see which approach better preserves heart function and prevents serious events like heart failure or stroke.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 217 people

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

Started

Sep 2022

Expected to finish

Dec 2027

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.

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: * Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe) * No indication for the surgical treatment at the time of enrolment * LV ejection fraction \>50% * Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease Exclusion Criteria: * Age \<18 years * Clearance Creatinine \<30 mL/min * Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue) * Pregnancy * Permanent atrial fibrillation.

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency

As listed by the trial registrant

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

Aortic valve regurgitation

How to take part

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

  1. The places running it

    7 sites in 3 countries. 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

  • 2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague

    RECRUITING

    Prague, 128 08, Czechia

  • Cardiovascular Center OLV Clinic Aalst

    RECRUITING

    Aalst, 9300, Belgium

  • Center of Cardiovascular and Transplant Surgery

    RECRUITING

    Brno, 65691, Czechia

  • International Clinical Research Center, St. Anne´s University Hospital Brno

    ACTIVE_NOT_RECRUITING

    Brno, 656 91, Czechia

  • Na Homolce Hospital

    RECRUITING

    Prague, 150 30, Czechia

  • Nemocnice AGEL Třinec-Podlesí

    RECRUITING

    Třinec, 73961, Czechia

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Hospital Hradec Králové

    RECRUITING

    Hradec Králové, 50005, Czechia

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