Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders

NCT04856267 | Completed

• 1 other identifier: 20/NS/0038
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this study is to improve our understanding of the effects of the build-up of amyloid deposits in the heart, in particular, our understanding of the risk of abnormal heart beats, or rhythms, associated with people with cardiac (heart) amyloidosis. Symptoms such as palpitations (fast, strong or irregular heart beat) and blackouts are common in people with cardiac amyloidosis, but there is not enough information on what causes this. At present, there is also not enough information on when they occur, how often they happen, and which patients are at risk of having serious, life-threatening types of abnormal heart rhythms. Some of these abnormal heart rhythms can be treated with medicine; others need electronic devices (e.g. pacemakers) implanted or inserted in the heart to prevent serious harm. The information on when is the best time to implant these life-saving devices remains limited. In this study, a small device known as an implantable loop recorder (ILR) will be implanted under the skin on the chest wall to continuously monitor participants' heart rhythm. This will help us answer some of the questions about what causes the abnormal heart rhythms, when they happen, and which patients are particularly likely to have them. Furthermore, it may help us to identify earlier, rather than later, those who are at risk of developing abnormal heart rhythms. This may lead to improvements in the care of people with cardiac amyloidosis in the future. Participants may not directly benefit from taking part in this study; however, there is a chance that the ILR may reveal heart rhythm abnormalities in some participants which might not be picked up otherwise, and so may lead to a change in their treatment.

Conditions

Arrythmia; Cardiac Amyloidosis; Sudden Cardiac Death

Keywords

Implantable Loop Recorder; Arrhythmia; Sudden Cardiac Death; Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Explore the characteristics (incidence and nature) of significant heart rhythm disturbances in subjects with cardiac amyloidosis by means of implantable cardiac monitor (ILR)

  Primary outcome measure is the presence of any clinically significant heart rhythm abnormality as revealed from the implantable cardiac monitor (ILR) over the course of the study

  Through study completion, up to 3 years

Secondary Outcomes (1)

• Examine the correlation between the characteristics of cardiac arrhythmias, as revealed by implantable cardiac monitor (ILR) with findings from other structural and functional assessment performed as standard of care (SOC)

  Through study completion, up to 3 years

Study Arms (1)

Cardiac Amyloidosis study cohort

Eligible patients will undergo subcutaneous implantation of a cardiac monitor device (Brand name - LINQ device, Medtronic - referred to in the application as "implantable loop recorder" or "ILR")

Device: LINQ device - implantable cardiac monitor - referred to in the application as "implantable loop recorder" or "ILR")

Interventions

LINQ device - implantable cardiac monitor - referred to in the application as "implantable loop recorder" or "ILR") DEVICE

Implantation of an implantable cardiac monitor device (brand name LINQ device, Medtronic) will be performed under local anaesthetic using an aseptic sterile technique. They will undergo frequent follow-up and monitoring for arrhythmias through remote monitoring of the device

Cardiac Amyloidosis study cohort

Eligibility Criteria

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

Study Population

Patients attending the National Amyloidosis Centre

You may qualify if:

• Age over 18 years
• Diagnosed with cardiac AL amyloidosis or cardiac ATTR amyloidosis using standard diagnostic techniques and criteria at the NAC
• Willing and able to provide written informed consent

You may not qualify if:

• Patient who already have a cardiac device inserted, such as a permanent pacemaker (PPM), implantable cardioverter-defibrillator (ICD) or implantable cardiac monitor (ILR)
• Other pre-existing cardiac or other pathology which, in the investigators opinion, would adverse affect primary outcome data collection
• Contraindication to CMR imaging

Sponsors & Collaborators

• Marianna Fontana: lead

Study Sites (1)

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (13)

• Falk RH, Comenzo RL, Skinner M. The systemic amyloidoses. N Engl J Med. 1997 Sep 25;337(13):898-909. doi: 10.1056/NEJM199709253371306. No abstract available.

  PMID: 9302305 BACKGROUND

• Kyle RA, Gertz MA. Primary systemic amyloidosis: clinical and laboratory features in 474 cases. Semin Hematol. 1995 Jan;32(1):45-59. No abstract available.

  PMID: 7878478 BACKGROUND

• Wechalekar AD, Gillmore JD, Hawkins PN. Systemic amyloidosis. Lancet. 2016 Jun 25;387(10038):2641-2654. doi: 10.1016/S0140-6736(15)01274-X. Epub 2015 Dec 21.

  PMID: 26719234 BACKGROUND

• Kyle RA, Linos A, Beard CM, Linke RP, Gertz MA, O'Fallon WM, Kurland LT. Incidence and natural history of primary systemic amyloidosis in Olmsted County, Minnesota, 1950 through 1989. Blood. 1992 Apr 1;79(7):1817-22.

  PMID: 1558973 BACKGROUND

• Dubrey SW, Cha K, Anderson J, Chamarthi B, Reisinger J, Skinner M, Falk RH. The clinical features of immunoglobulin light-chain (AL) amyloidosis with heart involvement. QJM. 1998 Feb;91(2):141-57. doi: 10.1093/qjmed/91.2.141.

  PMID: 9578896 BACKGROUND

• Grogan M, Dispenzieri A. Natural history and therapy of AL cardiac amyloidosis. Heart Fail Rev. 2015 Mar;20(2):155-62. doi: 10.1007/s10741-014-9464-5.

  PMID: 25447844 BACKGROUND

• Falk RH, Rubinow A, Cohen AS. Cardiac arrhythmias in systemic amyloidosis: correlation with echocardiographic abnormalities. J Am Coll Cardiol. 1984 Jan;3(1):107-13. doi: 10.1016/s0735-1097(84)80436-2.

  PMID: 6317729 BACKGROUND

• Lin G, Dispenzieri A, Kyle R, Grogan M, Brady PA. Implantable cardioverter defibrillators in patients with cardiac amyloidosis. J Cardiovasc Electrophysiol. 2013 Jul;24(7):793-8. doi: 10.1111/jce.12123. Epub 2013 Mar 14.

  PMID: 23489983 BACKGROUND

• Varr BC, Zarafshar S, Coakley T, Liedtke M, Lafayette RA, Arai S, Schrier SL, Witteles RM. Implantable cardioverter-defibrillator placement in patients with cardiac amyloidosis. Heart Rhythm. 2014 Jan;11(1):158-62. doi: 10.1016/j.hrthm.2013.10.026. Epub 2013 Oct 10. No abstract available.

  PMID: 24121001 BACKGROUND

• Hamon D, Algalarrondo V, Gandjbakhch E, Extramiana F, Marijon E, Elbaz N, Selhane D, Dubois-Rande JL, Teiger E, Plante-Bordeneuve V, Damy T, Lellouche N. Outcome and incidence of appropriate implantable cardioverter-defibrillator therapy in patients with cardiac amyloidosis. Int J Cardiol. 2016 Nov 1;222:562-568. doi: 10.1016/j.ijcard.2016.07.254. Epub 2016 Aug 1.

  PMID: 27513652 BACKGROUND

• Epstein AE, Dimarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities. Heart Rhythm. 2008 Jun;5(6):e1-62. doi: 10.1016/j.hrthm.2008.04.014. Epub 2008 May 21. No abstract available.

  PMID: 18534360 BACKGROUND

• Andrews CM, Srinivasan NT, Rosmini S, Bulluck H, Orini M, Jenkins S, Pantazis A, McKenna WJ, Moon JC, Lambiase PD, Rudy Y. Electrical and Structural Substrate of Arrhythmogenic Right Ventricular Cardiomyopathy Determined Using Noninvasive Electrocardiographic Imaging and Late Gadolinium Magnetic Resonance Imaging. Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e005105. doi: 10.1161/CIRCEP.116.005105.

  PMID: 28705875 BACKGROUND

• Sayed RH, Rogers D, Khan F, Wechalekar AD, Lachmann HJ, Fontana M, Mahmood S, Sachchithanantham S, Patel K, Hawkins PN, Whelan CJ, Gillmore JD. A study of implanted cardiac rhythm recorders in advanced cardiac AL amyloidosis. Eur Heart J. 2015 May 7;36(18):1098-105. doi: 10.1093/eurheartj/ehu506. Epub 2014 Dec 29.

  PMID: 25549725 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Amyloid Neuropathies, Familial; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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; Heart Arrest; Death, Sudden; Death

Study Officials

• Marianna Fontana

  principle investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Cardiology and Clinical Lead of the UCL Cardiac CMR service

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 23, 2021
• Study Start: May 27, 2021
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

GB (1)