Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.
A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MARVEL algorithm | Device | Software download into implanted Micra device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrioventricular synchrony | On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave. | Initial 24 hour period after patient enrollment |
| MARVEL Evolve Substudy | 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. | Initial 24 hour period after patient enrollment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Additional criteria for the MARVEL Evolve Sub-study:
Inclusion criteria:
• Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | United States | ||
| Baptist Hospital |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami |
| Florida |
| 33176 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322-1059 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Kepler Universitätsklinikum Med Campus III | Linz | 4021 | Austria |
| UZ Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| Nemocnice Na Homolce | Prague | Czech Republic | 150 30 | Czechia |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| Hôpital Haut-Lévêque - CHU de Bordeaux | Pessac | 33604 | France |
| Maria Cecilia Hospital | Cotignola | Ravenna | 48033 | Italy |
| Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello | Pisa | 56100 | Italy |
| Institut Jantung Negara | Kuala Lumpur | 50400 | Malaysia |
| Hospital Universitari Clínic de Barcelona | Barcelona | 08036 | Spain |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |