NCT07784712|Not Yet Recruiting
Right Ventricular Septal Biopsy to Detect Cardiac Amyloidosis
RV-CAM
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RV-CAM
Sponsor study identifier
Secondary identifiers
OTHER · Geisinger
observational
70
0 countries
N/A
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2026
Actual (reported)August 25, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Safety Events
From enrollment to the end of treatment at 15-21 months
Patients who are receiving a cardiac device as standard of care in the Geisinger Health System
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.
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.
Tissue. Three types of biopsies will be performed for specimen analysis: chest wall fat-pad, endomyocardial and deep septal biopsies
Pugazhendhi Vijayaraman, MD
Geisinger Clinic
First Submitted
August 21, 2026
First Posted
August 25, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2028
EstimatedContact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 25, 2026
Record last verified: 2026-08
This study is to assess feasibility of biopsy in a patient population specifically at Geisinger.
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