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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930980
Other study ID # MDT16023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2016
Est. completion date April 25, 2017

Study information

Verified date November 2018
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date April 25, 2017
Est. primary completion date April 25, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Investigational Software loaded on Micra device
Subject will receive an investigational software loaded on subject's Micra device

Locations

Country Name City State
Austria Kepler Universitätsklinikum Linz
France Hôpital cardiologique du Haut-Lévêque Pessac
France CHRU Tours - Hopital Trousseau Tours
Spain Hospital Clinic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Austria,  France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
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.
For approximately two hours after software download
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