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Can a heart monitor let TAVI patients go home sooner?

NCT ID NCT07456280

Knowledge-focused Sponsor: Hospital Universitari Vall d'Hebron Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study looks at whether people with heart rhythm problems after a TAVI procedure can safely leave the hospital early if they wear a non-invasive heart monitor at home. About 100 adults who had a successful TAVI for severe aortic stenosis and have certain conduction disorders will be enrolled. The goal is to see if this approach reduces deaths and hospital readmissions compared to standard 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.

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 100 people

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

Started

Jul 2026

Expected to finish

Aug 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: All inclusion criteria must be met * Age ≥ 18 years and * Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and * Presence of at least one of the following conduction disorders and * Pre-procedural basal conduction disorder (e.g., right/left bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec. * De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec. * Clinical stability at 24 hours post-procedure and * Capacity to give informed consent. Exclusion Criteria: No exclusion criteria must be met * Immediate indication for permanent pacemaker following the procedure. * Persistent complete atrioventricular block. * QRS \>160 msec and/or PR prolongation. * Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge. * Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system. * Life expectancy \< 12 months due to non-cardiovascular comorbidity. * Refusal or inability to undergo outpatient follow-up. * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiac conduction defect cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Severe aortic valve stenosis

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

  • Hospital Unniversitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

More trials for these conditions

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