Micra Accelerometer Sensor Study 2

Not Applicable

Completed

• Conditions: Bradyarrhythmia
• Interventions: Device: Investigational Software loaded on Micra device

• Registration Number: NCT02930980
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Study Start: 2016-10-14
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Results First Submitted: 2018-01-30
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Software	Investigational Software loaded on Micra device	Investigational Software loaded on Micra device

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Hôpital cardiologique du Haut-Lévêque; 🇫🇷 Pessac, France

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

CHRU Tours - Hopital Trousseau; 🇫🇷 Tours, France

Hospital Clinic; 🇪🇸 Barcelona, Spain