Micra Accelerometer Sensor Study 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bradyarrhythmia
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 43
- Locations
- 4
- Primary Endpoint
- Waveform and Components of Accelerometer Signal
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 18 years old
- •Subject is implanted with a Micra device
- •Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent
Exclusion Criteria
- •Subject is in atrial fibrillation
- •Subject is not able to perform study requirements
Outcomes
Primary Outcomes
Waveform and Components of Accelerometer Signal
Time Frame: For approximately two hours after software download
Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3). Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling.