Atrioventricular Conduction Block
Conditions
Brief summary
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.
Interventions
DEVICEMARVEL algorithm
Software download into implanted Micra device
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 witness, as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements. * Subject is willing and able to comply with the protocol.
Exclusion criteria
* Subject is in atrial arrhythmia at the time of enrollment. * Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. * Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL study procedures). * Subject meets any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrioventricular synchrony | Initial 24 hour period after patient enrollment | On an individual heartbeat basis, this is defined as a right ventricular paced or sensed R-wave associated with an ECG confirmed P-wave. |
| MARVEL Evolve Substudy | Initial 24 hour period after patient enrollment | 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. |
Countries
Austria, Belgium, Czechia, Denmark, France, Italy, Malaysia, Spain, United States
Outcome results
None listed