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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04421040
Other study ID # 17-006298
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2020
Est. completion date March 22, 2023

Study information

Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 22, 2023
Est. primary completion date March 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Biotronik Biomonitor 3 implant of device
The Biotronik Biomonitor 3 device will be implanted by the research team physician.
Biotronik Biomonitor 3 explant of device
The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sudden Death Total number of patients to experience sudden death 6 months
Primary Atrial Arrhythmias Total number of participants to experience atrial arrhythmias 6 months
Primary High Grade Atrioventricular (AV) Block Total number of patients with high grade atrioventricular (AV) block. 6 months
Primary Permanent Pacemaker Implantation Total number of patients requiring permanent pacemaker implantation. 6 months
See also
  Status Clinical Trial Phase
Completed NCT03481972 - A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin Phase 3