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

Last updated: March 19, 2024
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Amyloidosis

Treatment

Biotronic 3 implant of device

Biotronik Biomonitor 3 implant of device

Biotronik Biomonitor 3 explant of device

Clinical Study ID

NCT04421040
17-006298
  • Ages 18-85
  • All Genders

Study 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

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 EFor 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 aspacemakers or defibrillators

Exclusion

Exclusion Criteria:

  • Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardialvessel (by cardiac catheterization or coronary computed tomography), or history ofmyocardial 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 orhypertrophic 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 lifeexpectancy 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

Total Participants: 24
Treatment Group(s): 4
Primary Treatment: Biotronic 3 implant of device
Phase:
Study Start date:
October 07, 2020
Estimated Completion Date:
March 22, 2023

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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