Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06738537

Conditions

Mitral Valve Prolapse

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Focus Groups/Quantitative Survey for Patients

Focus Group/Quantitative Survey for HCPs

Qualitative Focus Group

Study Details

Brief summary:

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.

Conditions

Mitral Valve Prolapse

Study ID

NCT06738537

Start date

Sep 1, 2023

Status verified date

Dec, 2024

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Jan 28, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 21 years and older
  • Diagnosis of degenerative mitral valve regurgitation

Exclusion Criteria:

  • Non-English speaking
  • Unable to consent on own behalf
  • Previous mitral surgery

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Health Care Providers

We will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation.

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.

Interventions

Focus Groups/Quantitative Survey for Patients

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

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

Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.

Primary outcome measure

  • Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR [ Time Frame: 1 year ]
  • Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR [ Time Frame: 1 year ]
  • Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Nancy Stone, MEd, NBC-HWC

816-932-5367nanstone@saint-lukes.org

Shangyi Liu, MS

516-757-5949sliu11@northwell.edu

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Achille Peiris

310-423-3277achille.peiris@cshs.org

Maria Thottam

310-423-3277maria.thottam@cshs.org

Principal Investigator:

Joanna Chickwe, MD

Saint Luke's Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Nancy Stone, MEd, NBC-HWC

816-932-5367nanstone@saint-lukes.org

Christine Fuss, RN

816-932-5363cfuss@saint-lukes.org

Principal Investigator:

Stacy Farr, PhD

Northwell Health

Recruiting

New York, New York, United States, 10075

Contacts

Shangyi Liu, MS

516-757-5949sliu11@northwell.edu

Efstathia Mihelis, PA-C, MBA

516-474-3745emihelis@northwell.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Mary Alice Bowman

216-444-2200BOWMANM3@ccf.org

Laurie Ann Moennich

216-444-2200

Principal Investigator:

Marc Gillinov, MD

West Virginia University Medicine

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Josh Bombard

304-598-4000josh.bombard@wvumedicine.org

Kimberly Quedado

3045984000kq10006@wvumedicine.org

Principal Investigator:

Vinay Badhwar, MD

More Information

Sponsor

Northwell Health

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Keywords

  • transcatheter edge-to-edge repair
  • surgical mitral valve repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-12-17.