A Study to Monitor Cardiac Amyloidosis Patients with Implantable Event Monitors

Overview

About this study

The primary purpose of this study is to assess arrhythmic events using the implantable cardiac monitor, Biomonitor 3, in subjects presenting to the clinic with TTR-wt cardiac amyloidosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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.
  • Patients who already have an ICD or PPM implanted.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grace Lin, M.D.

Open for enrollment

Contact information:

Melissa Rott R.N.

(507) 266-2504

Rott.Melissa@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available