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Micra Accelerometer Sensor Study 2 (MASS2)

Primary Purpose

Bradyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Investigational Software loaded on Micra device
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bradyarrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kepler Universitätsklinikum
  • Hôpital cardiologique du Haut-Lévêque
  • CHRU Tours - Hopital Trousseau
  • Hospital Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Software

Arm Description

Investigational Software loaded on Micra device

Outcomes

Primary Outcome Measures

Waveform and Components of Accelerometer Signal
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2016
Last Updated
November 26, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02930980
Brief Title
Micra Accelerometer Sensor Study 2
Acronym
MASS2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
April 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Software
Arm Type
Experimental
Arm Description
Investigational Software loaded on Micra device
Intervention Type
Device
Intervention Name(s)
Investigational Software loaded on Micra device
Intervention Description
Subject will receive an investigational software loaded on subject's Micra device
Primary Outcome Measure Information:
Title
Waveform and Components of Accelerometer Signal
Description
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.
Time Frame
For approximately two hours after software download

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Hôpital cardiologique du Haut-Lévêque
City
Pessac
Country
France
Facility Name
CHRU Tours - Hopital Trousseau
City
Tours
Country
France
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29758405
Citation
Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.
Results Reference
derived

Learn more about this trial

Micra Accelerometer Sensor Study 2

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