Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart patch after valve surgery: could it save lives?

NCT ID NCT07521800

Diagnosis Sponsor: Medical University of Silesia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether wearing a portable ECG monitor for 30 days after a heart valve replacement (TAVI) can detect dangerous heart rhythm problems better than the usual 1-2 days of hospital monitoring. 250 patients will be randomly assigned to either the extended monitoring group or standard care. The goal is to see if longer monitoring leads to earlier treatment and fewer complications.

What this could mean

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

Active substance
Remote ECG monitoring device
What this could lead to
If successful, this could show that continuous home ECG monitoring after TAVI catches dangerous heart rhythm issues earlier than standard hospital checks, leading to faster treatment.
What could go wrong
This is a relatively small trial (250 people) and is not testing a new drug or cure. The monitoring may find extra issues that don't actually need treatment, causing unnecessary worry or procedures.

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 250 people

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

Started

Dec 2023

Expected to finish

Feb 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.

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: * Patient age over 18 years old * Severe aortic stenosis * Moderate or high cardiovascular risk based on current ESC Guidelines "Heart Team" qualification for TAVI * Written informed consent of the patient for participation in the study Exclusion Criteria: * History of atrial fibrillation or atrial flutter * Previously known conduction disturbances\*\* * Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI * Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification * Haemorrhagic stroke within 1 year before TAVI qualification * Chronic immunosuppressive therapy * Comorbidities (e.g. drug addiction, alcohol abuse, emotional/mental disorders) which do not allow safe participation in the study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Arrythmia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac atrial fibrillation atrioventricular block cardiac rhythm disease

As listed by the trial registrant

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

Arrythmia Atrial fibrillation (AF) Atrioventricular block Remote monitoring 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

    4 sites in 2 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

  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

    NOT_YET_RECRUITING

    Katowice, 40-635, Poland

  • Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland

    RECRUITING

    Bialystok, Poland

  • Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza

    RECRUITING

    Turin, Italy

  • Medical University of Silesia

    RECRUITING

    Katowice, 40-055, Poland

More trials for these conditions

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