Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis

NCT07784712 | Not Yet Recruiting

• 2 other identifiers: 2026-0781Clinic Research Fund
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy); Heart Failure

Keywords

cardiac amyloidosis; cardiac device

Outcome Measures

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

  From enrollment to the end of treatment at 15-21 months.

Secondary Outcomes (1)

• Safety Events

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

Eligibility Criteria

• Age: 50 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are receiving a cardiac device as standard of care in the Geisinger Health System

You may qualify if:

• 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)

You may not qualify if:

• Inability to provide informed consent
• Pregnant
• Enrolled in a concurrent study that may confound the results of this study

Sponsors & Collaborators

• Geisinger Clinic: lead

Related Publications (13)

• Morishita K, Fujiu K, Yamagata K, Amiya E, Takeda N. Right ventricular myocardial biopsy with a guiding catheter for conduction system pacing during pacemaker implantation revealed transthyretin cardiac amyloidosis. HeartRhythm Case Rep. 2024 Jun 19;10(9):635-638. doi: 10.1016/j.hrcr.2024.06.008. eCollection 2024 Sep. No abstract available.

  PMID: 39355814 BACKGROUND

• Zhang C, Musikantow DR, Pugliese DN, Mitter SS, Koruth J, Moss N, Mancini DM, Dukkipati SR, Reddy VY, Miller MA. Chest-Wall Adipose Tissue Excisional Biopsy During Pacemaker or Defibrillator Implantation: New Technique to Diagnose Amyloidosis. J Am Coll Cardiol. 2022 Jul 5;80(1):93-94. doi: 10.1016/j.jacc.2022.05.002. No abstract available.

  PMID: 35772920 BACKGROUND

• Vijayaraman P, Chelu MG, Curila K, Dandamudi G, Herweg B, Mori S, Jastrzebski M, Sharma PS, Shivkumar K, Tung R, Upadhyay G, Vernooy K, Welter-Frost A, Whinnett Z, Zanon F, Ellenbogen KA. Cardiac Conduction System Pacing: A Comprehensive Update. JACC Clin Electrophysiol. 2023 Nov;9(11):2358-2387. doi: 10.1016/j.jacep.2023.06.005. Epub 2023 Aug 16.

  PMID: 37589646 BACKGROUND

• Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20.

  PMID: 37283271 BACKGROUND

• Witteles RM, Bokhari S, Damy T, Elliott PM, Falk RH, Fine NM, Gospodinova M, Obici L, Rapezzi C, Garcia-Pavia P. Screening for Transthyretin Amyloid Cardiomyopathy in Everyday Practice. JACC Heart Fail. 2019 Aug;7(8):709-716. doi: 10.1016/j.jchf.2019.04.010. Epub 2019 Jul 10.

  PMID: 31302046 BACKGROUND

• Mohammed SF, Mirzoyev SA, Edwards WD, Dogan A, Grogan DR, Dunlay SM, Roger VL, Gertz MA, Dispenzieri A, Zeldenrust SR, Redfield MM. Left ventricular amyloid deposition in patients with heart failure and preserved ejection fraction. JACC Heart Fail. 2014 Apr;2(2):113-22. doi: 10.1016/j.jchf.2013.11.004.

  PMID: 24720917 BACKGROUND

• Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.

  PMID: 26224076 BACKGROUND

• Kittleson MM, Maurer MS, Ambardekar AV, Bullock-Palmer RP, Chang PP, Eisen HJ, Nair AP, Nativi-Nicolau J, Ruberg FL; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology. Cardiac Amyloidosis: Evolving Diagnosis and Management: A Scientific Statement From the American Heart Association. Circulation. 2020 Jul 7;142(1):e7-e22. doi: 10.1161/CIR.0000000000000792. Epub 2020 Jun 1.

  PMID: 32476490 BACKGROUND

• Nguyen FD, Rodriguez M, Krittanawong C, Witteles R, Lenihan DJ. Misconceptions and Facts About Cardiac Amyloidosis. Am J Cardiol. 2021 Dec 1;160:99-105. doi: 10.1016/j.amjcard.2021.08.045. Epub 2021 Oct 3.

  PMID: 34610875 BACKGROUND

• Hartnett J, Jaber W, Maurer M, Sperry B, Hanna M, Collier P, Patel DR, Wazni OM, Donnellan E. Electrophysiological Manifestations of Cardiac Amyloidosis: JACC: CardioOncology State-of-the-Art Review. JACC CardioOncol. 2021 Oct 19;3(4):506-515. doi: 10.1016/j.jaccao.2021.07.010. eCollection 2021 Oct.

  PMID: 34729522 BACKGROUND

• Lane T, Fontana M, Martinez-Naharro A, Quarta CC, Whelan CJ, Petrie A, Rowczenio DM, Gilbertson JA, Hutt DF, Rezk T, Strehina SG, Caringal-Galima J, Manwani R, Sharpley FA, Wechalekar AD, Lachmann HJ, Mahmood S, Sachchithanantham S, Drage EPS, Jenner HD, McDonald R, Bertolli O, Calleja A, Hawkins PN, Gillmore JD. Natural History, Quality of Life, and Outcome in Cardiac Transthyretin Amyloidosis. Circulation. 2019 Jul 2;140(1):16-26. doi: 10.1161/CIRCULATIONAHA.118.038169. Epub 2019 May 21.

  PMID: 31109193 BACKGROUND

• Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.

  PMID: 29048471 BACKGROUND

• Grogan M, Scott CG, Kyle RA, Zeldenrust SR, Gertz MA, Lin G, Klarich KW, Miller WL, Maleszewski JJ, Dispenzieri A. Natural History of Wild-Type Transthyretin Cardiac Amyloidosis and Risk Stratification Using a Novel Staging System. J Am Coll Cardiol. 2016 Sep 6;68(10):1014-20. doi: 10.1016/j.jacc.2016.06.033.

  PMID: 27585505 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue. Three types of biopsies will be performed for specimen analysis: chest wall fat-pad, endomyocardial and deep septal biopsies

MeSH Terms

Conditions

Heart Failure; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Pugazhendhi Vijayaraman, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Hughes, BS, MPH

CONTACT

570-808-3461; gehughes@geisinger.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share