Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors

Mayo Clinic

Status: Completed

Conditions: TTR Cardiac Amyloidosis

Treatments: Device: Biotronik Biomonitor 3 explant of device; Device: Biotronik Biomonitor 3 implant of device

Study type: Interventional

Funder types: Other

Identifiers

NCT04421040

17-006298

Details and patient eligibility

About

Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Biomonitor 3

Experimental group

Description:

Placement of Biotronik Biomonitor 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronik Biomonitor 3 device removed.

Treatment:

Device: Biotronik Biomonitor 3 explant of device

Device: Biotronik Biomonitor 3 implant of device