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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2023-03-22

Brief Summary

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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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Detailed Description

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Conditions

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TTR Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Biomonitor 3

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.

Group Type EXPERIMENTAL

Biotronik Biomonitor 3 implant of device

Intervention Type DEVICE

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

Biotronik Biomonitor 3 explant of device

Intervention Type DEVICE

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

Interventions

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Biotronik Biomonitor 3 implant of device

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

Intervention Type DEVICE

Biotronik Biomonitor 3 explant of device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No