Bradyarrhythmia
Conditions
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.
Interventions
DEVICEInvestigational Software loaded on Micra device
Subject will receive an investigational software loaded on subject's Micra device
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waveform and Components of Accelerometer Signal | 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. |
Countries
Austria, France, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Software Investigational Software loaded on Micra device
Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Investigational Software | — |
|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 15 | — |
| Body Mass Index | 27.6 kg/m^2 STANDARD_DEVIATION 4.4 | — |
| Diastolic Blood Pressure | 76.2 mm Hg STANDARD_DEVIATION 13.7 | — |
| Height | 167 cm STANDARD_DEVIATION 10.5 | — |
| Implant Duration | 369 days STANDARD_DEVIATION 354 | — |
| Implant Location RV Apex | 22 Participants | — |
| Implant Location RV Mid Septum | 7 Participants | — |
| Implant Location RV Septum | 14 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 14 participants | — |
| Region of Enrollment France | 20 participants | — |
| Region of Enrollment Spain | 9 participants | — |
| Rhythm at time of software download Atrial Fibrillation (AF) | 1 Participants | — |
| Rhythm at time of software download Atrial Tachycardia (AT) | 1 Participants | — |
| Rhythm at time of software download Sinus with 2nd or 3rd Atrioventricular block | 10 Participants | — |
| Rhythm at time of software download Sinus without 2nd or 3rd Atrioventricular block | 31 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
| Systolic Blood Pressure | 138.9 mm Hg STANDARD_DEVIATION 26.5 | — |
| Weight | 76.5 kg STANDARD_DEVIATION 14.9 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Waveform and Components of Accelerometer Signal
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.
Time frame: For approximately two hours after software download
Population: Of the 43 subjects enrolled, 12 with Atrial tachycardia / Atrial fibrillation and 2nd degree or greater atrioventricular block were excluded from analysis since the A4 signal is absent or variable. An additional 4 subjects in sinus rhythm were excluded from analysis due to frequent pacing or telemetry noise, resulting in 27 subjects for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Software | Waveform and Components of Accelerometer Signal | A4 (g) in V1 | 0.15601 g (unit (g) represent acceleration) | Standard Deviation 0.089 |
| Investigational Software | Waveform and Components of Accelerometer Signal | A4 (g) in V2 | 0.19222 g (unit (g) represent acceleration) | Standard Deviation 0.11058 |
| Investigational Software | Waveform and Components of Accelerometer Signal | A4 (g) in V3 | 0.14398 g (unit (g) represent acceleration) | Standard Deviation 0.08532 |