Micra Accelerometer Sensor Study 2

Bradyarrhythmia Clinical Trial

— MASS2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930980
• Other study ID #: MDT16023
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

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