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

Mitral Regurgitation Clinical Trial

— VELOCITY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02858245
• Other study ID #: 16-6001
• Status: Terminated
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Other:
• No intervention - registry

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Baptist Hospital of Miami	Miami	Florida
United States	Banner University Medical Center	Phoenix	Arizona
United States	Bon Secours St Mary's Hospital	Richmond	Virginia
United States	Mayo Foundation for Medical Education and Research	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 30 days
Secondary	Levels of daily and weekly activity as assessed by actigraphy		Pre-procedure (on day 0)
Secondary	Levels of daily and weekly activity as assessed by actigraphy		Post-procedure (= 7 days)
Secondary	Levels of daily and weekly activity as assessed by actigraphy		At 30 days
Secondary	Levels of daily and weekly activity as assessed by actigraphy		At 2 months
Secondary	Levels of daily and weekly activity as assessed by actigraphy		At 3 months
Secondary	Levels of daily and weekly activity as assessed by actigraphy		At 4 months
Secondary	Levels of daily and weekly activity as assessed by actigraphy		At 5 months
Secondary	Patterns of daily Sleep/Wake by actigraphy		At 6 months
Secondary	NYHA Functional Class		At Baseline
Secondary	NYHA Functional Class		At 30 days
Secondary	Mitral Regurgitation severity		At Baseline
Secondary	Mitral Regurgitation severity		Post-procedure (= 7 days)
Secondary	Mitral Regurgitation severity		At 30 days
Secondary	Echocardiographic assessment		At Baseline
Secondary	Echocardiographic assessment		Post-procedure (= 7 days)
Secondary	Echocardiographic assessment		At 30 days
Secondary	Distance walked 6 minute walk test (6MWT)		At Baseline
Secondary	Distance walked 6 minute walk test (6MWT)		At 30 days
Secondary	Health-related quality of life (QoL)		At Baseline
Secondary	Health-related quality of life (QoL)		At 30 days