Micra Accelerometer Sensor Study 2
MASS2
1 other identifier
interventional
43
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedStudy Start
First participant enrolled
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedResults Posted
Study results publicly available
March 11, 2019
CompletedMarch 11, 2019
November 1, 2018
6 months
October 6, 2016
January 30, 2018
November 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
For approximately two hours after software download
Study Arms (1)
Investigational Software
EXPERIMENTALInvestigational Software loaded on Micra device
Interventions
Subject will receive an investigational software loaded on subject's Micra device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subject is in atrial fibrillation
- Subject is not able to perform study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kepler Universitätsklinikum
Linz, 4020, Austria
Hôpital cardiologique du Haut-Lévêque
Pessac, France
CHRU Tours - Hopital Trousseau
Tours, France
Hospital Clinic
Barcelona, Spain
Related Publications (1)
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.
PMID: 29758405DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Valentina Amori, Medical Writer
- Organization
- Medtronic EMEA RCC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2016
First Posted
October 12, 2016
Study Start
October 14, 2016
Primary Completion
April 25, 2017
Study Completion
April 25, 2017
Last Updated
March 11, 2019
Results First Posted
March 11, 2019
Record last verified: 2018-11