← Back to all trials
Not Yet Recruiting
NCT07784712
Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis
Conditions: ATTR-CM (Transthyretin Amyloid Cardiomyopathy), Heart Failure
Sex: All
Ages: 50 Years – 105 Years
Healthy volunteers: No
Enrollment: 70
Sponsor: Geisinger Clinic
Summary
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 Criteria
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
Source: ClinicalTrials.gov (NCT07784712). StuddyBuddy aggregates publicly available trial information.