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

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

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

Conditions
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TTR Cardiac Amyloidosis

Intervention / Treatment
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* Device: Biotronic 3 implant of device
* Device: Biotonic 3 explant of device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 50 patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biomonitor 3<br>Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed. | Device: Biotronic 3 implant of device<br>* The Biotronic 3 device will be implanted by the research team physician.<br>Device: Biotonic 3 explant of device<br>* The Biotronic 3 device will be removed from the patient by the research team physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudden death | Total number of patients with sudden death | 6 months | 
| Atrial arrhythmias | Frequency of atrial arrhythmias | 6 months | 
| High grade AV block | Total number of patients with high grade AV block | 6 months | 
| Sinus node dysfunction | Total number of patients with sinus node dysfunction | 6 months |