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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02858245

Acronym

VELOCITY

Enrollment

Registered

2016-08-08

Start date

2016-11-30

Completion date

2017-12-31

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

MitraClip, Structural Heart Failure, Degenerative Mitral Regurgitation (DMR), Actigraphy

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.

Interventions

OTHERNo intervention - registry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Distance walked 6 minute walk test (6MWT)	At Baseline
Health-related quality of life (QoL)	At Baseline
Levels of daily and weekly activity as assessed by actigraphy	Pre-procedure (on day 0)
Echocardiographic assessment	At Baseline
NYHA Functional Class	At Baseline
Mitral Regurgitation severity	At Baseline
Patterns of daily Sleep/Wake by actigraphy	At 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026