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Could a routine heart device implant reveal a hidden disease?

NCT ID NCT07784712

Diagnosis Sponsor: Geisinger Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study looks at whether taking a tiny tissue sample from the heart during a pacemaker or defibrillator implant can help diagnose transthyretin cardiac amyloidosis (ATTR-CM), a condition where abnormal proteins build up in the heart. The trial enrolls people aged 65 and older (or 50–64 with a family history or genetic risk) who are already scheduled for a heart device. Researchers will compare biopsy results from different heart areas to see how often they detect ATTR-CM in this at-risk group, while also tracking safety.

What this could mean

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

Active substance
Right ventricular septal biopsy (tissue sampling during cardiac device implantation)
What this could lead to
If successful, this could enable earlier detection of ATTR-CM in people already undergoing heart device implantation, potentially leading to earlier treatment and better outcomes.
What could go wrong
The study is small and exploratory, and the biopsy procedure carries risks such as pericardial tamponade. It is unclear if the biopsy will reliably detect ATTR-CM better than existing methods.

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.

Participants

About 70 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

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.

Who is studied

Patients who are receiving a cardiac device as standard of care in the Geisinger Health System

Ages

50 to 105 years

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: * Age≥65(or 50-64 with hereditary-ATTR risk: family history of ATTR or known TTR variant) * Patients with an indication for permanent pacemaker or CRT or ICD device * Patients willing to comply with all study procedures and be available for the duration of the study. And any one of the following: Diagnosis of atrial fibrillation or sinus node dysfunction Diagnosis of AV block Heart failure with preserved ejection fraction Heart failure with reduced ejection fraction Evidence for infiltrative cardiomyopathy Unexplained renal insufficiency Peripheral neuropathy Family h/o cardiomyopathy Family h/o peripheral neuropathy Carpal tunnel syndrome, unprovoked tendon rupture Hip or knee arthroplasty Unexplained RV or LV wall thickening on echocardiogram Unexplained, persistent low-level elevation of cardiac troponins Unexplained orthostatic hypotension Discordance between QRS voltage on ECG and wall thickness on echo Black race Spinal stenosis IVS thickness ≥ 1.2cm (by TTE or cardiac MRI) Exclusion Criteria: * Inability to provide informed consent * Pregnant * Enrolled in a concurrent study that may confound the results of this study

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial heart failure wild type ATTR amyloidosis

As listed by the trial registrant

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

Attr-CM (transthyretin amyloid cardiomyopathy) Heart failure

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 ↗

  2. A doctor treating you

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