Study Stopped
Study has been terminated due to small sample size
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
VELOCITY
A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device
1 other identifier
observational
30
1 country
8
Brief Summary
A prospective, open-label, and multi-centered feasibility registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 7, 2018
May 1, 2017
1.1 years
July 20, 2016
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (20)
Levels of daily and weekly activity as assessed by actigraphy
Pre-procedure (on day 0)
Levels of daily and weekly activity as assessed by actigraphy
Post-procedure (≤ 7 days)
Levels of daily and weekly activity as assessed by actigraphy
At 30 days
Levels of daily and weekly activity as assessed by actigraphy
At 2 months
Levels of daily and weekly activity as assessed by actigraphy
At 3 months
- +15 more secondary outcomes
Study Arms (1)
Commercial MitraClip® patients
Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device
Interventions
Eligibility Criteria
Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Banner University Medical Center
Phoenix, Arizona, 85006, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Mayo Foundation for Medical Education and Research
Rochester, Minnesota, 55905, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Bon Secours St Mary's Hospital
Richmond, Virginia, 23226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Staehr, MD
Abbott Medical Devices
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 8, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 7, 2018
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share