Bradyarrhythmia Clinical Trial
— MASS2Verified date | November 2018 |
Source | Medtronic Cardiac Rhythm and Heart Failure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | April 25, 2017 |
Est. primary completion date | April 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Austria | Kepler Universitätsklinikum | Linz | |
France | Hôpital cardiologique du Haut-Lévêque | Pessac | |
France | CHRU Tours - Hopital Trousseau | Tours | |
Spain | Hospital Clinic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
Austria, France, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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