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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Software | Experimental | Investigational Software loaded on Micra device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Software loaded on Micra device | Device | Subject will receive an investigational software loaded on subject's Micra device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum | Linz | 4020 | Austria | |||
| Hôpital cardiologique du Haut-Lévêque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29758405 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Software | Investigational Software loaded on Micra device Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Software | Investigational Software loaded on Micra device Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 43 subjects enrolled, 12 with Atrial tachycardia / Atrial fibrillation and 2nd degree or greater atrioventricular block were excluded from analysis since the A4 signal is absent or variable. An additional 4 subjects in sinus rhythm were excluded from analysis due to frequent pacing or telemetry noise, resulting in 27 subjects for analysis. | Posted | Mean | Standard Deviation | g (unit (g) represent acceleration) | For approximately two hours after software download |
|
Adverse Events (AEs) were collected for each subject since subject enrollment until subject study exit (approx 2 hours).
The definition of adverse event and/or serious adverse event used to collect adverse event information, does not differ from the clinical trials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Software | Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valentina Amori, Medical Writer | Medtronic EMEA RCC | +39 06 32814236 | valentina.amori@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2016 | Dec 21, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Pessac |
| France |
| CHRU Tours - Hopital Trousseau | Tours | France |
| Hospital Clinic | Barcelona | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | The difference between row population and overall is due to missing data. | Mean | Standard Deviation | cm |
|
| Body Mass Index | The difference between row population and overall is due to missing data. | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | The difference between row population and overall is due to missing data. | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | The difference between row population and overall is due to missing data. | Mean | Standard Deviation | mm Hg |
|
| Implant Duration | Mean | Standard Deviation | days |
|
| Implant Location | Count of Participants | Participants |
|
| Rhythm at time of software download | Count of Participants | Participants |
|
Investigational Software loaded on Micra device Investigational Software loaded on Micra device: Subject will receive an investigational software loaded on subject's Micra device |
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |