TTR Cardiac Amyloidosis
Conditions
Brief summary
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
Interventions
DEVICEBiotronik Biomonitor 3 implant of device
The Biotronik Biomonitor 3 device will be implanted by the research team physician.
DEVICEBiotronik Biomonitor 3 explant of device
The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sudden Death | 6 months | Total number of patients to experience sudden death |
| Atrial Arrhythmias | 6 months | Total number of participants to experience atrial arrhythmias |
| High Grade Atrioventricular (AV) Block | 6 months | Total number of patients with high grade atrioventricular (AV) block. |
| Permanent Pacemaker Implantation | 6 months | Total number of patients requiring permanent pacemaker implantation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biomonitor 3 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.
Biotronik Biomonitor 3 implant of device: The Biotronik Biomonitor 3 device will be implanted by the research team physician.
Biotronik Biomonitor 3 explant of device: The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Biomonitor 3 |
|---|---|
| Age, Continuous | 75 years STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 24 |
| other Total, other adverse events | 8 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Atrial Arrhythmias
Total number of participants to experience atrial arrhythmias
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biomonitor 3 | Atrial Arrhythmias | 10 Participants |
Primary
High Grade Atrioventricular (AV) Block
Total number of patients with high grade atrioventricular (AV) block.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biomonitor 3 | High Grade Atrioventricular (AV) Block | 2 Participants |
Primary
Permanent Pacemaker Implantation
Total number of patients requiring permanent pacemaker implantation.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biomonitor 3 | Permanent Pacemaker Implantation | 3 Participants |
Primary
Sudden Death
Total number of patients to experience sudden death
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biomonitor 3 | Sudden Death | 0 Participants |