A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
- Conditions
- Mitral Regurgitation
- Registration Number
- NCT02858245
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
A prospective, open-label, and multi-centered feasibility registry.
- Detailed Description
This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- Subject must consent to receiving the MitraClip device
- Subject must consent, be able, and commit to wearing the Actiwatch continuously for approximately 7 months
- Subject must consent to use of their data from this registry for purposes of exploratory research and publication and presentation
- Subject is not a member of vulnerable population
- Subject must not have any disabilities that preclude reliable data collection from the Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will require walking aids, etc.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation At 30 days Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure
- Secondary Outcome Measures
Name Time Method Levels of daily and weekly activity as assessed by actigraphy At 5 months Echocardiographic assessment At 30 days Distance walked 6 minute walk test (6MWT) At 30 days Health-related quality of life (QoL) At 30 days Patterns of daily Sleep/Wake by actigraphy At 6 months NYHA Functional Class At 30 days Mitral Regurgitation severity At 30 days
Trial Locations
- Locations (8)
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Mayo Foundation for Medical Education and Research
🇺🇸Rochester, Minnesota, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Bon Secours St Mary's Hospital
🇺🇸Richmond, Virginia, United States
Banner University Medical Center🇺🇸Phoenix, Arizona, United States