Clinical trial NCT02858245: A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device
Official title: A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mitral Regurgitation
Keywords: MitraClip
Structural Heart Failure
Degenerative Mitral Regurgitation (DMR)
Actigraphy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation
timeFrame: At 30 days
Secondary outcomes:
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: Pre-procedure (on day 0)
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: Post-procedure (≤ 7 days)
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: At 30 days
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: At 2 months
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: At 3 months
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: At 4 months
measure: Levels of daily and weekly activity as assessed by actigraphy
timeFrame: At 5 months
measure: Patterns of daily Sleep/Wake by actigraphy
timeFrame: At 6 months
measure: NYHA Functional Class
timeFrame: At Baseline
measure: NYHA Functional Class
timeFrame: At 30 days
measure: Mitral Regurgitation severity
timeFrame: At Baseline
measure: Mitral Regurgitation severity
timeFrame: Post-procedure (≤ 7 days)
measure: Mitral Regurgitation severity
timeFrame: At 30 days
measure: Echocardiographic assessment
timeFrame: At Baseline
measure: Echocardiographic assessment
timeFrame: Post-procedure (≤ 7 days)
measure: Echocardiographic assessment
timeFrame: At 30 days
measure: Distance walked 6 minute walk test (6MWT)
timeFrame: At Baseline
measure: Distance walked 6 minute walk test (6MWT)
timeFrame: At 30 days
measure: Health-related quality of life (QoL)
timeFrame: At Baseline
measure: Health-related quality of life (QoL)
timeFrame: At 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Rochester
country: United States
facility: Mayo Foundation for Medical Education and Research
state: Minnesota
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Richmond
country: United States
facility: Bon Secours St Mary's Hospital
state: Virginia
Study officials:
affiliation: Abbott Medical Devices
name: Peter Staehr, MD
role: STUDY_DIRECTOR
References: