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

Not Applicable

Completed

• Conditions: TTR Cardiac Amyloidosis
• Interventions: Device: Biotronik Biomonitor 3 implant of device; Device: Biotronik Biomonitor 3 explant of device

• Registration Number: NCT04421040
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Study Start: 2020-10-07
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Status Verified: 2024-03
• Results First Submitted: 2024-03-19
• Results First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Results First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biomonitor 3	Biotronik Biomonitor 3 implant of device	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.
Biomonitor 3	Biotronik Biomonitor 3 explant of device	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States