Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis

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).

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Key information

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy) Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Age range

50 year–105 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Cardiac biopsy results

Time frame: From enrollment to the end of treatment at 15-21 months.
- ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy
- Overall percentage of positive results in this high-risk population

Secondary outcomes

Safety Events

Time frame: From enrollment to the end of treatment at 15-21 months

Safety events (i.e., pericardial tamponade)

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Hughes, BS, MPH

CONTACT

[email protected]

570-808-3461

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Acronym: RV-CAM

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 25, 2026
Registry last updated: Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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