NCT04856267Completed
Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 110 (actual)
- First submitted
- 13 Apr 2021
- Start date
- 27 May 2021
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Marianna Fontana
- Diseases
- Amyloidosis
- NCT number
- NCT04856267
What you commit to
- Study type: Observational
- Participants enrolled: 110
- From 27 May 2021 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Contraindication to CMR imaging
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
Related publications
- Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders: The EXCALIBUR Study.J Am Coll Cardiol · 2026 · PMID 42201646
This page is information, not medical advice. Discuss any trial with your doctor.