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

Study Overview
=================
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.

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

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Other: No intervention - registry


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Commercial MitraClip® patients<br>Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device | Other: No intervention - registry<br> <br> |

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 | Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure | At 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MitraClip, Structural Heart Failure, Degenerative Mitral Regurgitation (DMR), Actigraphy