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

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

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

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