CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
LINQ device - implantable cardiac monitor - referred to in the application as "implantable loop recorder" or "ILR")device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04856267
NCT04856267N/ACompleted

Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders

Marianna Fontana·observational·Posted Apr 23, 2021·Updated Jan 20, 2026

In Brief

An observational study evaluating LINQ device - implantable cardiac monitor - referred to in the application as "implantable loop recorder" or "ILR") for Arrythmia and 2 related conditions. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 23, 2021
Enrollment StartMay 27, 2021
Primary CompletionJul 1, 2025
Study CompletionOct 1, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.2 years ago

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