Patient-centered decision-making for mitral valve prolapse treatment
Official title: Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
Run by Northwell Health · NCT06738537 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | January 28, 2024 |
| Study ends | February 28, 2025 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT06738537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 21 and older diagnosed with degenerative mitral valve regurgitation.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Predicting high-risk arrhythmic events in people with arrhythmic mitral valve prolapse
This study tests a risk model to see which patients with arrhythmic mitral valve prolapse might need an ICD.
-
AI and 3D ultrasound mapping of mitral valve prolapse shape and function.
This project tests an automated AI system that uses intraoperative 3D transesophageal ultrasound to map mitral valve anatomy and create patient-specific biomechanical models for adults having surgery for degenerative mitral valve prolapse.
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Korea VHD Echo Study: Real-World Practice of Aortic, Mitral, and Tricuspid Valves
This study looks at how valvular heart disease is managed in Korea by reviewing echocardiograms and medical records from multiple centers to see patterns in disease progression and treatment.
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Predicting heart muscle scarring in patients with mitral valve prolapse
This study is trying to find out if a new scoring system can help identify patients with mitral valve prolapse who are at risk for heart muscle scarring and related problems using heart imaging.
-
Impact of mitral valve surgery on ventricular arrhythmias
This study is testing how mitral valve surgery helps people with mitral valve prolapse and arrhythmias by looking at their heart health before and after the operation.
-
Observational registry for patients treated with the NeoChord Artificial Chordae System
This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.