Clinical trial NCT04421040: Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Official title: Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TTR Cardiac Amyloidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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 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

Primary outcomes:
measure: Sudden Death
timeFrame: 6 months
measure: Atrial Arrhythmias
timeFrame: 6 months
measure: High Grade Atrioventricular (AV) Block
timeFrame: 6 months
measure: Permanent Pacemaker Implantation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Omar Abou Ezzeddine, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: