Trial Outcomes & Findings for Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors (NCT NCT04421040)

NCT ID: NCT04421040

Last Updated: 2024-04-16

Results Overview

Total number of patients to experience sudden death

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

6 months

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biomonitor 3 n=24 Participants 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. 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.
Age, Continuous	75 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Total number of patients to experience sudden death

Outcome measures

Outcome measures
Measure	Biomonitor 3 n=24 Participants 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. 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.
Sudden Death	0 Participants

PRIMARY outcome

Timeframe: 6 months

Total number of participants to experience atrial arrhythmias

Outcome measures

Outcome measures
Measure	Biomonitor 3 n=24 Participants 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. 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.
Atrial Arrhythmias	10 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Biomonitor 3 n=24 Participants 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. 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.
High Grade Atrioventricular (AV) Block	2 Participants

PRIMARY outcome

Timeframe: 6 months

Total number of patients requiring permanent pacemaker implantation.

Outcome measures

Outcome measures
Measure	Biomonitor 3 n=24 Participants 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. 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.
Permanent Pacemaker Implantation	3 Participants

Adverse Events

Biomonitor 3

Serious events: 0 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Biomonitor 3 n=24 participants at risk 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. 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.
Cardiac disorders Heart palpitations	16.7% 4/24 • Number of events 4 • Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.
General disorders Fatigue	12.5% 3/24 • Number of events 3 • Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.
General disorders Syncope	8.3% 2/24 • Number of events 2 • Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.

Additional Information

Dr. Grace Lin

Mayo Clinic

Phone: 507-255-1267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place