A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device

Abbott Medical Devices30 enrolled

Overview

A prospective, open-label, and multi-centered feasibility registry.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mitral Regurgitation

Interventions

No intervention - registryOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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

Outcomes

Primary Outcomes

Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation

Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure

Time frame: At 30 days