Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03157297 | Micra Atrial Tracking Using a Ventricular Accelerometer Study | PHASE1 | COMPLETED | 70 | — | — | Jul 10, 2017 | Nov 24, 2017 | Oct 26, 2018 | 13 | United States, Austria +7 |
On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave.
Characterize the rate of atrioventricular synchrony provided by the MARVEL algorithm and compare the accelerometer signal amplitudes and the AV synchrony provided by the MARVEL algorithm with the data collected during the initial MARVEL procedure.
| Arm | Type | Description |
|---|---|---|
| Enrolled | EXPERIMENTAL | Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device. |
| Name | Type | Description |
|---|---|---|
| MARVEL algorithm | DEVICE | Software download into implanted Micra device |
Inclusion Criteria: * Subject has been implanted with, or is expected to be implanted with a MicraTM TPS (Model MC1VR01), with remaining device longevity of 6 years or more. * Subject is ≥ 18 years old and as per required local law. * Subject has atrioventricular (AV) block. * Subject (and/or witne...