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

Abbott

Status: Terminated

Conditions: Mitral Regurgitation

Treatments: Other: No intervention - registry

Study type: Observational

Funder types: Industry

Identifiers

NCT02858245

16-6001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Commercial MitraClip® patients

Description:

Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device

Treatment:

Other: No intervention - registry