An observational study in ATTR-CM (Transthyretin Amyloid Cardiomyopathy) and Heart Failure, sponsored by Geisinger Clinic. Not yet recruiting. Open to participants aged 50 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Geisinger Clinic · Observational
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).
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:
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 70 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Geisinger Clinic is the lead sponsor of 127 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are receiving a cardiac device as standard of care in the Geisinger Health System
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of atrial fibrillation or sinus node dysfunction Diagnosis of AV block Heart failure with preserved 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 and wall thickness on echo Black race Spinal stenosis IVS thickness ≥ 1.2cm (by TTE or cardiac MRI)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardiac biopsy results
* ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy * Overall percentage of positive results in this high-risk population
Time frame: From enrollment to the end of treatment at 15-21 months.
Safety Events
Safety events (i.e., pericardial tamponade)
Time frame: From enrollment to the end of treatment at 15-21 months
No study locations are listed for this record.
Plan to share: No — This study is to assess feasibility of biopsy in a patient population specifically at Geisinger.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 18 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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