Micra Accelerometer Sensor Study 2

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.

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum, Linz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational Software loaded on Micra device

Device

Subject will receive an investigational software loaded on subject's Micra device

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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: MASS2

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 12, 2016
Registry last updated: Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed