Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

Part of paid clinical trials in Los Angeles, California.

Sponsor
Northwell Health
Study ID
NCT06738537
Status
Recruiting

Conditions

  • Mitral Valve Prolapse

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focus Groups/Quantitative Survey for Patients — OTHER
    5 quantitative focus groups will be conducted with 5-10 patients each to elicit the range of outcomes patients consider important when selecting treatment options. 100 quantitative surveys to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
  • Focus Group/Quantitative Survey for HCPs — OTHER
    5 quantitative focus groups will be conducted with 5-10 providers to elicit the range of outcomes providers consider important when recommending treatment options to patients. 100 quantitative surveys to characterize how providers prioritize outcomes for patients with severe MR when making treatment recommendations.
  • Qualitative Focus Group — OTHER
    Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.

Study Details

This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Findings from this study will provide data that can be used to develop decision aids that can assist patients in decision making between these two therapies and assist providers in integrating shared decision making the within the multidisciplinary heart valve team.

Key Dates

Start date
Sep 1, 2023
Status verified
Dec 2024
Primary completion
Jan 28, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Patients with MR
    We will recruit patients with degenerative mitral regurgitation (MR) who are presenting to a surgeon or cardiologist for consultation regarding management of their valve disease.
  • Arm: Health Care Providers
    We will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation.
  • Arm: Multidisciplinary Mitral Valve Heart Team
    We will recruit members of multidisciplinary mitral valve heart teams including cardiac surgeons, cardiologists, nurses, and ancillary staff. These providers will be involved in caring for patients who presents to multidisciplinary heart teams for evaluation of their mitral valve disease.

Primary Outcome Measure

Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR [ Time Frame: 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Achille Peiris
310-423-3277
Maria Thottam
310-423-3277
Joanna Chickwe, MD (PRINCIPAL_INVESTIGATOR)
Saint Luke's HospitalKansas CityMissouri64111
Nancy Stone, MEd, NBC-HWC
816-932-5367
Christine Fuss, RN
816-932-5363
Stacy Farr, PhD (PRINCIPAL_INVESTIGATOR)
Danielle Olds, PhD, RN (SUB_INVESTIGATOR)
Northwell HealthNew YorkNew York10075
Shangyi Liu, MS
516-757-5949
Efstathia Mihelis, PA-C, MBA
516-474-3745
Cleveland ClinicClevelandOhio44195
Mary Alice Bowman
216-444-2200
Laurie Ann Moennich
216-444-2200
Marc Gillinov, MD (PRINCIPAL_INVESTIGATOR)
West Virginia University MedicineMorgantownWest Virginia26506
Josh Bombard
304-598-4000
Kimberly Quedado
3045984000
Vinay Badhwar, MD (PRINCIPAL_INVESTIGATOR)

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