[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653230":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":22,"studyPopulation":23,"armGroups":18,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":34,"collaborators":18,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":18,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"Geisinger Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Cardiac biopsy results","* ATTR-CM positive results of fat-pad biopsy, endomyocardial biopsy, and deep septal biopsy\n* Overall percentage of positive results in this high-risk population","From enrollment to the end of treatment at 15-21 months.",[14],{"measure":15,"description":16,"timeFrame":17},"Safety Events","Safety events (i.e., pericardial tamponade)","From enrollment to the end of treatment at 15-21 months",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"CASE_ONLY","PROSPECTIVE","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.\n\nSpecific Objectives:\n\n* To assess the incidence of ATTR-CM in at-risk patients undergoing permanent pacemaker implantation\n* To develop a workflow for the diagnosis of ATTR-CM in pacemaker-indicated patients\n* To assess the utility of chest wall fat pad biopsy from the pacemaker pocket in the diagnosis of amyloidosis\n* To assess the utility of endomyocardial biopsy at the time of pacemaker implant in the diagnosis of ATTR-CM in an at-risk population\n\nThe 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.","Patients who are receiving a cardiac device as standard of care in the Geisinger Health System",[25],{"name":26,"affiliation":5,"role":27},"Pugazhendhi Vijayaraman, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Grace Hughes, BS, MPH","CONTACT","570-808-3461","gehughes@geisinger.edu",{"type":35,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100653230","right-ventricular-septal-biopsy-to-detect-cardiac-amyloidosis-100653230",false,"NCT07784712","Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis","Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis in At-Risk Population: A Prospective Study","RV-CAM","Inclusion Criteria:\n\n* Age≥65(or 50-64 with hereditary-ATTR risk: family history of ATTR or known TTR variant)\n* Patients with an indication for permanent pacemaker or CRT or ICD device\n* Patients willing to comply with all study procedures and be available for the duration of the study. And any one of the following:\n\nDiagnosis 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\u002Fo cardiomyopathy Family h\u002Fo 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)\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Pregnant\n* Enrolled in a concurrent study that may confound the results of this study","ALL","50 Years","105 Years",{"count":48,"type":49},70,"ESTIMATED","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).",[53,54],"ATTR-CM (Transthyretin Amyloid Cardiomyopathy)","Heart Failure",[56,57],"cardiac amyloidosis","cardiac device","NOT_YET_RECRUITING","2026-08-21",{"date":61,"type":62},"2026-08-25","ACTUAL",{"date":64,"type":49},"2026-10",{"date":66,"type":49},"2028-08",{"name":5,"class":6}]