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Trial Outcomes & Findings for Micra Accelerometer Sensor Study 2 (NCT NCT02930980)

NCT ID: NCT02930980

Last Updated: 2019-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

For approximately two hours after software download

Results posted on

2019-03-11

Participant Flow

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
43
Overall Study
COMPLETED
43
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Investigational Software
n=43 Participants
Investigational Software loaded on Micra device Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device
Age, Continuous
73 years
STANDARD_DEVIATION 15 • n=43 Participants
Sex: Female, Male
Female
13 Participants
n=43 Participants
Sex: Female, Male
Male
30 Participants
n=43 Participants
Region of Enrollment
Austria
14 participants
n=43 Participants
Region of Enrollment
France
20 participants
n=43 Participants
Region of Enrollment
Spain
9 participants
n=43 Participants
Weight
76.5 kg
STANDARD_DEVIATION 14.9 • n=43 Participants
Height
167 cm
STANDARD_DEVIATION 10.5 • n=42 Participants • The difference between row population and overall is due to missing data.
Body Mass Index
27.6 kg/m^2
STANDARD_DEVIATION 4.4 • n=42 Participants • The difference between row population and overall is due to missing data.
Systolic Blood Pressure
138.9 mm Hg
STANDARD_DEVIATION 26.5 • n=42 Participants • The difference between row population and overall is due to missing data.
Diastolic Blood Pressure
76.2 mm Hg
STANDARD_DEVIATION 13.7 • n=41 Participants • The difference between row population and overall is due to missing data.
Implant Duration
369 days
STANDARD_DEVIATION 354 • n=43 Participants
Implant Location
RV Septum
14 Participants
n=43 Participants
Implant Location
RV Apex
22 Participants
n=43 Participants
Implant Location
RV Mid Septum
7 Participants
n=43 Participants
Rhythm at time of software download
Sinus without 2nd or 3rd Atrioventricular block
31 Participants
n=43 Participants
Rhythm at time of software download
Atrial Tachycardia (AT)
1 Participants
n=43 Participants
Rhythm at time of software download
Atrial Fibrillation (AF)
1 Participants
n=43 Participants
Rhythm at time of software download
Sinus with 2nd or 3rd Atrioventricular block
10 Participants
n=43 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Investigational Software
n=27 Participants
Investigational Software loaded on Micra device Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device
Waveform and Components of Accelerometer Signal
A4 (g) in V3
0.14398 g (unit (g) represent acceleration)
Standard Deviation 0.08532
Waveform and Components of Accelerometer Signal
A4 (g) in V1
0.15601 g (unit (g) represent acceleration)
Standard Deviation 0.08900
Waveform and Components of Accelerometer Signal
A4 (g) in V2
0.19222 g (unit (g) represent acceleration)
Standard Deviation 0.11058

Adverse Events

Investigational Software

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valentina Amori, Medical Writer

Medtronic EMEA RCC

Phone: +39 06 32814236

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60