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Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders

NCT04856267 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-01-20

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Marianna Fontana

    lead OTHER

Principal Investigators

  • Marianna Fontana · principle investigator

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2025-07-01
Completion
2025-10-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856267 on ClinicalTrials.gov