Back to resultsLong-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Primary Purpose
TTR Cardiac Amyloidosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biotronic 3 implant of device
Biotonic 3 explant of device
Sponsored by
About this trial
This is an interventional prevention trial for TTR Cardiac Amyloidosis
Eligibility Criteria
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.
- Unwilling or able to have the Biomonitor 3 interrogated
- Patients who already have an ICD or PPM implanted.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biomonitor 3
Arm Description
Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed.
Outcomes
Primary Outcome Measures
Sudden death
Total number of patients with sudden death
Atrial arrhythmias
Frequency of atrial arrhythmias
High grade AV block
Total number of patients with high grade AV block
Sinus node dysfunction
Total number of patients with sinus node dysfunction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04421040
Brief Title
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Official Title
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TTR Cardiac Amyloidosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
50 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biomonitor 3
Arm Type
Experimental
Arm Description
Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed.
Intervention Type
Device
Intervention Name(s)
Biotronic 3 implant of device
Intervention Description
The Biotronic 3 device will be implanted by the research team physician.
Intervention Type
Device
Intervention Name(s)
Biotonic 3 explant of device
Intervention Description
The Biotronic 3 device will be removed from the patient by the research team physician.
Primary Outcome Measure Information:
Title
Sudden death
Description
Total number of patients with sudden death
Time Frame
6 months
Title
Atrial arrhythmias
Description
Frequency of atrial arrhythmias
Time Frame
6 months
Title
High grade AV block
Description
Total number of patients with high grade AV block
Time Frame
6 months
Title
Sinus node dysfunction
Description
Total number of patients with sinus node dysfunction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Lin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Rott, RN
Phone
507-266-2504
Email
Rott.Melissa@mayo.edu
First Name & Middle Initial & Last Name & Degree
Grace Lin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
We'll reach out to this number within 24 hrs