Micra Accelerometer Sensor Study 2 (MASS2)

Medtronic

Status: Completed

Conditions: Bradyarrhythmia

Treatments: Device: Investigational Software loaded on Micra device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02930980

MDT16023

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

43 participants in 1 patient group

Investigational Software

Experimental group

Description:

Investigational Software loaded on Micra device

Treatment:

Device: Investigational Software loaded on Micra device