Micra Atrial Tracking Using a Ventricular Accelerometer Study
- Conditions
- Atrioventricular Conduction Block
- Interventions
- Device: MARVEL algorithm
- Registration Number
- NCT03157297
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 exclusion criteria required by local law (age or other).
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enrolled MARVEL algorithm Subjects enrolled in the MARVEL study. Enrolled subjects will have the MARVEL algorithm downloaded into their implanted market released Micra device.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Baptist Hospital
🇺🇸Miami, Florida, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Kepler Universitätsklinikum Med Campus III
🇦🇹Linz, Austria
Nemocnice Na Homolce
🇨🇿Praha 5, Czech Republic, Czechia
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Odense Universitetshospital
🇩🇰Odense C, Denmark
Maria Cecilia Hospital
🇮🇹Cotignola, Ravenna, Italy
Hôpital Haut-Lévêque - CHU de Bordeaux
🇫🇷Pessac, France
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
🇮🇹Pisa, Italy
Institut Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Hospital Universitari Clínic de Barcelona
🇪🇸Barcelona, Spain