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Pacemaker signals may unmask a rare heart condition

NCT ID NCT07734285

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study explores whether the electrical signal measured by a pacemaker or defibrillator during implantation can help identify cardiac amyloidosis — a condition where abnormal proteins build up in the heart. Researchers will enroll 242 adults aged 65 and older who already need a pacemaker due to heart rhythm problems and also have thickened heart walls. Alongside standard implantation, participants will receive extra tests including a heart scan, blood work, and a small fat biopsy to confirm or rule out amyloidosis. The goal is to see if the pacemaker's readings alone can reliably flag the disease.

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 provide a simple, low-cost way to screen for cardiac amyloidosis during routine pacemaker implantation.
What could go wrong
This is an early diagnostic study, not a treatment trial. The electrical signal test may not prove accurate enough to replace standard biopsies or scans.

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 242 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2030

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

65 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 referred for CIED implantation (pacemaker or Implantable Cardioverter Defibrillator with a pacemaker feature) due to at least one conduction abnormality (Atrioventricular block, Sinoatrial block or Atrial fibrillation with slow ventricular rate). Patients referred for implantation of an Implantable Cardioverter Defibrillator with a pacemaker feature can be included if they present one of these conduction abnormalities. * Left ventricular hypertrophy definite as maximal end-diastolic interventricular septum thickness ≥ 12mm * Patients aged ≥ 65 years * Written consent * Patient affiliated to a social security Exclusion Criteria: * Severe aortic stenosis (valve area ≤ 1 cm2) * Known cardiac amyloidosis * Indication for cardiac resynchronisation therapy * Indication for left bundle branch physiological pacing * Ejection fraction \< 45% on echocardiography. * Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants. * Patient on AME (state medical aid) * Adults subject to a legal protection measure (guardianship, curatorship, or safeguard of justice). * Patients deprived of their liberty by a judicial or administrative decision.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis conduction system disorder Hypertrophy, Left Ventricular

As listed by the trial registrant

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

Cardiac amyloidosis Conduction abnormality Left ventricular hypertrophy

How to take part

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  1. 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 ↗

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More trials for these conditions

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