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OpenTrials
Completed

NCT Number: NCT04421040

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.
  • 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

Treatment and study plan

Biotronik Biomonitor 3 implant of device

Device

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

Biotronik Biomonitor 3 explant of device

Device

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

Primary outcomes

  1. Sudden Death

    Time frame: 6 months

    Total number of patients to experience sudden death

  2. Atrial Arrhythmias

    Time frame: 6 months

    Total number of participants to experience atrial arrhythmias

  3. High Grade Atrioventricular (AV) Block

    Time frame: 6 months

    Total number of patients with high grade atrioventricular (AV) block.

  4. Permanent Pacemaker Implantation

    Time frame: 6 months

    Total number of patients requiring permanent pacemaker implantation.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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