Last updated: March 19, 2024
Sponsor: Mayo Clinic
Overall Status: Completed
Phase
N/A
Condition
Amyloidosis
Treatment
Biotronic 3 implant of device
Biotronik Biomonitor 3 implant of device
Biotronik Biomonitor 3 explant of device
Clinical Study ID
NCT04421040
17-006298
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 EFor 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 aspacemakers or defibrillators
Exclusion
Exclusion Criteria:
- Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardialvessel (by cardiac catheterization or coronary computed tomography), or history ofmyocardial 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 orhypertrophic 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 lifeexpectancy 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
Study Design
Total Participants: 24
Treatment Group(s): 4
Primary Treatment: Biotronic 3 implant of device
Phase:
Study Start date:
October 07, 2020
Estimated Completion Date:
March 22, 2023
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesSite Not Available

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