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.

Study Overview

• Status: Completed
• Conditions: TTR Cardiac Amyloidosis
• Intervention / Treatment: Device: Biotronik Biomonitor 3 implant of device; Device: Biotronik Biomonitor 3 explant of device

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amyloid Research Team; Phone Number: (507) 266-4426
• Study Contact Backup: Name: Omar Abou Ezzeddine, MD, MS; Phone Number: (507) 422-6183; Email: AbouEzzeddine.Omar@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Biotronik Biomonitor 3 implant of device; The Biotronik Biomonitor 3 device will be implanted by the research team physician.; Device: Biotronik Biomonitor 3 explant of device; The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden Death	Total number of patients to experience sudden death	6 months
Atrial Arrhythmias	Total number of participants to experience atrial arrhythmias	6 months
High Grade Atrioventricular (AV) Block	Total number of patients with high grade atrioventricular (AV) block.	6 months
Permanent Pacemaker Implantation	Total number of patients requiring permanent pacemaker implantation.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Omar Abou Ezzeddine, MD, MS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 17-006298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes