New study aims to cut unnecessary pacemakers after TAVI

NCT ID NCT05308888

Knowledge-focused Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether inflammation after a minimally invasive heart valve replacement (TAVI) can cause dangerous heart rhythm problems. Researchers will use a special PET scan to measure inflammation in the heart's electrical pathways. The goal is to better predict which patients truly need a pacemaker, avoiding unnecessary implants and their risks.

What this could mean

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

Active substance: 18F-FDG (a radioactive tracer used in PET scans)
What this could lead to: If successful, this could help doctors predict which patients truly need a pacemaker after TAVI, avoiding unnecessary implants and their complications.
What could go wrong: This is an early exploratory study with only 100 participants, so results may not apply to everyone. It uses imaging to observe inflammation, not to test a new treatment.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Nov 2022

Expected to finish

Nov 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: * Major patient (\>18 years of age); * Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest; * Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction \< 50% ; * Patient with vascular anatomy compatible with percutaneous femoral valve implantation; * Patient affiliated to or benefiting from a health insurance plan; * Patient who has provided free, informed and written consent. Exclusion Criteria: * Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation; * Patient with a uni or bicuspid aortic valve; * Patient with severe left ventricular dysfunction LVEF \< 30%; * Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ; * Patient with iliofemoral vascular anatomy preventing safe passage of the valve; * Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position; * Inability or refusal to consent; * Pregnant or breastfeeding woman; * Patient under judicial protection or family habilitation; * Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship; * Patient with life expectancy \< 12 months.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Aortic valve stenosis

How to take part

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

The places running it

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

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

New study aims to cut unnecessary pacemakers after TAVI

What the study statuses mean