Patient-centered decision-making for mitral valve prolapse treatment
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
This study is trying to understand what patients with mitral valve prolapse and their doctors think about choosing between two treatment options, surgery or a less invasive procedure, to help improve how they make decisions together.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06738537 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather insights from patients with degenerative mitral valve prolapse and healthcare providers regarding their preferences in choosing between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). By employing qualitative focus groups and quantitative surveys, the study will identify key factors influencing decision-making for these two treatment options. The findings will contribute to the development of decision aids that facilitate shared decision-making between patients and their multidisciplinary heart valve teams.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 and older diagnosed with degenerative mitral valve regurgitation.
Not a fit: Patients who are non-English speaking, unable to consent for themselves, or have previously undergone mitral surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient satisfaction and outcomes by aligning treatment decisions with patient preferences.
How similar studies have performed: Previous studies on decision-making in heart valve treatments have shown variability in patient and provider preferences, indicating the potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 4 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Saint Luke's Hospital — Kansas City, Missouri, United States (Recruiting)
- Northwell Health — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- West Virginia University Medicine — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Iribarne, MD, MS, FACC — Northwell Health
- Study coordinator: Nancy Stone, MEd, NBC-HWC
- Email: nanstone@saint-lukes.org
- Phone: 816-932-5367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.