Who may be eligible for the Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis trial?

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

ClinicalTrials.gov record NCT07784712

Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis in At-Risk Population: A Prospective Study

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age50 years old to 105 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study enrolls patients who are having a permanent pacemaker, CRT, or ICD implanted as part of routine care. During that procedure the study will collect chest wall fat‑pad, endomyocardial, and deep septal biopsies to look for transthyretin cardiac amyloidosis (ATTR‑CM). The team will measure how often biopsies are positive and record related safety events over about 15–21 months.

What it is studying. The study is testing whether tissue samples taken during a cardiac device implantation—chest wall fat‑pad biopsy and heart tissue biopsies (endomyocardial and deep septal)—detect transthyretin cardiac amyloidosis (ATTR‑CM) in an at‑risk population and to estimate how common ATTR‑CM is in this group.

What the researchers hope to learn. Scientific goals: assess the incidence of ATTR‑CM in this at‑risk population; develop a diagnostic workflow for pacemaker‑indicated patients; evaluate the diagnostic utility of chest wall fat‑pad, endomyocardial, and deep septal biopsies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

People eligible for this study have had the suggestion from their doctor to receive a cardiac pacemaker or defibrillator to treat a cardiac condition as part of their routine care. We are doing this study to understand if obtaining a tissue sample from their body during a device implant may assist in the early diagnosis of Transthyretin Cardiac Amyloidosis (ATTR-CM).

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The aim of our study is to assess the feasibility of using chest wall fat-pad biopsy and endomyocardial biopsy in early diagnosis of ATTR-CM in at-risk patients undergoing permanent pacemaker implantations. Specific Objectives:

To assess the incidence of ATTR-CM in at-risk patients undergoing permanent pacemaker implantation
To develop a workflow for the diagnosis of ATTR-CM in pacemaker-indicated patients
To assess the utility of chest wall fat pad biopsy from the pacemaker pocket in the diagnosis of amyloidosis
To assess the utility of endomyocardial biopsy at the time of pacemaker implant in the diagnosis of ATTR-CM in an at-risk population

The study team will enroll 70 patients who satisfy inclusion and exclusion criteria. The study team will assess the incidence of amyloidosis and the utility of chest wall fat-pad biopsy, endomyocardial biopsy and deep septal biopsy in the diagnosis of amyloidosis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

The study plans to enroll up to 70 patients who are receiving a permanent pacemaker, cardiac resynchronization therapy (CRT), or implantable cardioverter‑defibrillator (ICD) as part of routine care. During the device implantation, the study team will obtain a chest wall fat‑pad biopsy from the pacemaker pocket, an endomyocardial biopsy, and a deep septal biopsy. Collected tissue will be tested for transthyretin cardiac amyloidosis (ATTR‑CM), and safety events (for example, pericardial tamponade) will be recorded. Participants will be followed from enrollment through the end of the study at about 15–21 months.

How the study is structured. A prospective, observational, case‑only study. Participants undergo their planned device implantation as standard care; researchers collect specified biopsies during that procedure and follow participants for biopsy results and safety events. No treatments are assigned by the study. Follow‑up for outcomes is from enrollment through about 15–21 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under ATTR-CM (Transthyretin Amyloid Cardiomyopathy); Heart Failure. Does it apply to my diagnosis?
This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: October 2026 (estimated)
Primary completion: April 2028 (estimated)
Study completion: August 2028 (estimated)
Target enrollment: 70 participants (estimated)
Last updated on registry: Aug 25, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Geisinger Clinic

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Grace Hughes, BS, MPH 📞 570-808-3461 ✉ gehughes@geisinger.edu

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

echocardiogram: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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