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

May 2, 2018 updated by: Abbott Medical Devices

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Foundation for Medical Education and Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Bon Secours St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Commercial MitraClip® patients
Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device
Other: No intervention - registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
Time Frame: At 30 days
Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure
At 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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