Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-105
SponsorGeisinger Clinic
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide informed consent
Pregnant
Enrolled in a concurrent study that may confound the results of this study
Trial population
Patients who are receiving a cardiac device as standard of care in the Geisinger Health System
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
Safety Events
Safety events (i.e., pericardial tamponade)
Time frame
From enrollment to the end of treatment at 15-21 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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