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 — OTHER5 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 — OTHER5 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 — OTHERQualitative 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 MRWe 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 ProvidersWe will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation.
- Arm: Multidisciplinary Mitral Valve Heart TeamWe 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
- Nancy Stone, MEd, NBC-HWC816-932-5367
- Shangyi Liu, MS516-757-5949
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Joanna Chickwe, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | Stacy Farr, PhD (PRINCIPAL_INVESTIGATOR) Danielle Olds, PhD, RN (SUB_INVESTIGATOR) |
| Northwell Health | New York | New York | 10075 | |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Laurie Ann Moennich 216-444-2200 Marc Gillinov, MD (PRINCIPAL_INVESTIGATOR) |
| West Virginia University Medicine | Morgantown | West Virginia | 26506 | Vinay Badhwar, MD (PRINCIPAL_INVESTIGATOR) |
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