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

NCT04421040 | Completed Results FDA Device

• 1 other identifier: 17-006298
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TTR Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Biomonitor 3

EXPERIMENTAL

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; Device: Biotronik Biomonitor 3 explant of device

Interventions

Biotronik Biomonitor 3 implant of device DEVICE

The Biotronik Biomonitor 3 device will be implanted by the research team physician.

Biomonitor 3

Biotronik Biomonitor 3 explant of device DEVICE

The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.

Biomonitor 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Grace Lin
• Organization: Mayo Clinic

lin.grace@mayo.edu

507-255-1267

Study Officials

• Omar Abou Ezzeddine, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: October 7, 2020
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)