Mitral Valve Screening Survey
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mitral Valve Screening Survey (MVSS)
Overview
This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).
Detailed description
Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI.
In this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.
Primary outcome measures
- All-cause mortality [Time frame: 1 year]
Secondary outcome measures (4)
- Reason for screen failure [Time frame: Baseline]
- All-cause mortality [Time frame: 30 days, 1 year, and annually up to 5 years]
- Hospitalizations [Time frame: 30 days, 1 year, and annually up to 5 years]
- Mitral intervention [Time frame: 30 days, 1 year, and annually up to 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 14 centers
- Phoenix Cardiovascular Research Group — Phoenix
- Keck Hospital of USC — Los Angeles
- MedStar Washington Hospital Center — Washington D.C.
- Morton Plant Hospital — Clearwater
- HealthPark Medical Center — Fort Myers
- Northwestern University — Chicago
- MercyOne Iowa Heart Center — West Des Moines
- University of Kansas Medical Center — Kansas City
- … and 6 more centers
Canada · 2 centers
- St. Paul's Hospital — Vancouver
- Unity Health Toronto; St. Michael's Hospital — Toronto
Publications
- Medranda GA, Rogers T, Modine T, Latib A, Jorde U, Bapat V, Sorajja P, Rowland M, Sutton JA, Baig S, Asch FM, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. The Clinical Profile and Natural History of Patients Who Fail Screening for Transcatheter Mitral Valve Replacement: Rationale and Design of the Prospective Multicenter Mitral Valve Screening Survey (MVSS). Cardiovasc Revasc Med. 2023 Feb;4 PMID 36266153
- Waksman R, Medranda GA. Transcatheter Mitral Valve Replacement: Size Matters. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2228-2230. doi: 10.1016/j.jcin.2021.08.040. Epub 2021 Sep 29. No abstract available. PMID 34600872
Identifiers
NCT: NCT04736667 · MVSS