N/A N=43 Health Services Research

Micra Accelerometer Sensor Study 2

Bradyarrhythmia

Bottom Line

View on ClinicalTrials.gov: NCT02930980 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcome: Primary: Waveform and Components of Accelerometer Signal — 0.15601; 0.19222; 0.14398 g (unit (g) represent acceleration)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Investigational Software loaded on Micra device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Waveform and Components of Accelerometer Signal	0.15601; 0.19222; 0.14398	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02930980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.