Micra Accelerometer Sensor Study 2

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-14

Study Completion Date

2017-04-25

Brief Summary

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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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Detailed Description

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Conditions

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Bradyarrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Investigational Software

Investigational Software loaded on Micra device

Group Type EXPERIMENTAL

Investigational Software loaded on Micra device

Intervention Type DEVICE

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

Interventions

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Investigational Software loaded on Micra device

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

Intervention Type DEVICE

Eligibility Criteria

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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