N/A
N=24
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
TTR Cardiac Amyloidosis
Bottom Line
View on ClinicalTrials.gov: NCT04421040 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Sudden Death — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biotronik Biomonitor 3 implant of device (Device); Biotronik Biomonitor 3 explant of device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sudden Death |
— | — |
| PRIMARY Atrial Arrhythmias |
10 | — |
| PRIMARY High Grade Atrioventricular (AV) Block |
2 | — |
| PRIMARY Permanent Pacemaker Implantation |
3 | — |
Summary
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
Eligibility Criteria
Inclusion Criteria
- Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
- Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
- Patients aged 18 -85, both genders and of all races and ethnicities.
- Patients must be competent to give informed consent.
- Patients must be able to have the Biomonitor 3 implanted.
- Amyloid stage I-III patients with existing implantable cardiac devices such as pacemakers or defibrillators
Exclusion Criteria
- Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
- Congenital heart disease.
- Pregnant patients
- Patients whose heart failure is felt to be secondary to primary valvular disease (>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
- Absolute contraindications to cardiac MRI (such as renal failure with GFR<30%).
- Unwilling or unable to provide informed consent.
- Patients with other life threatening diseases that would likely decrease their life expectancy over the next four years.
- Patients who are post cardiac transplant.
- Difficulty to attend the follow-up schedule due to a history of medical noncompliance, difficulty, or unwillingness to return to the study center for follow up.
- Evidence of ongoing bacteremia or sepsis preventing implantation of a device
- Unwilling or able to have the Biomonitor 3 interrogated
Data sourced from ClinicalTrials.gov (NCT04421040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.