Survey of patients who fail screening for mitral valve interventions
Mitral Valve Screening Survey (MVSS)
This study is trying to learn more about patients who aren't eligible for a specific heart valve procedure to help improve future treatments for mitral valve disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 16 sites (Phoenix, Arizona and 15 other locations) |
| Trial ID | NCT04736667 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the clinical profiles and anatomical characteristics of patients who do not meet the screening criteria for transcatheter mitral valve interventions (TMVI). It will create a prospective multicenter registry that collects baseline demographics, imaging characteristics, and clinical outcomes of these patients. The goal is to better understand the natural history of mitral valve disease in those who are ineligible for TMVI, which could inform future treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have failed screening for transcatheter mitral valve interventions.
Not a fit: Patients who are under 18 years of age or those who have already proceeded with TMVI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve the selection criteria for TMVI, potentially expanding treatment options for patients with mitral valve disease.
How similar studies have performed: While there have been numerous studies on TMVI, this specific approach focusing on patients who fail screening is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject failed screening for TMVI Exclusion Criteria: * Under 18 years of age * Subject unable or unwilling to give informed consent * Subject proceeded with TMVI.
Where this trial is running
Phoenix, Arizona and 15 other locations
- Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States (Recruiting)
- Keck Hospital of USC — Los Angeles, California, United States (Recruiting)
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- Morton Plant Hospital — Clearwater, Florida, United States (Recruiting)
- HealthPark Medical Center — Fort Myers, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- MercyOne Iowa Heart Center — West Des Moines, Iowa, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Ascension St. John's Hospital — Detroit, Michigan, United States (Recruiting)
- NYU Langone Health - Long Island — Mineola, New York, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Oregon Health Sciences University — Portland, Oregon, United States (Recruiting)
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Unity Health Toronto; St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Kassandra Lopez
- Email: kassandra.lopez@medstar.net
- Phone: 202-877-2452
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.