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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
70
Software download into implanted Micra device
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Baptist Hospital
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
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.
Time frame: 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.
Time frame: Initial 24 hour period after patient enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NYU Langone Medical Center
New York, New York, United States
Kepler Universitätsklinikum Med Campus III
Linz, Austria
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
Nemocnice Na Homolce
Prague, Czech Republic, Czechia
Odense Universitetshospital
Odense C, Denmark
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, France
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
...and 3 more locations