Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Rhythm and Heart Failure
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Subjects in the MARVEL Sub-Study have previously been enrolled in the MARVEL main study
You may not be if
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).
Additional criteria for the MARVEL Evolve Sub-study:
Clareo Health | Micra Atrial Tracking Using a Ventricular Accelerometer Study
