Status:
COMPLETED
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Lead Sponsor:
Mayo Clinic
Conditions:
TTR Cardiac Amyloidosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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
- 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
- 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
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04421040
Start Date
October 7 2020
End Date
March 22 2023
Last Update
April 16 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905