Clinical trial NCT04736667: Mitral Valve Screening Survey
Official title: Mitral Valve Screening Survey (MVSS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This multicenter prospective study will enroll consecutive subjects, who after referral for TMVI, are deemed not to be candidates for TMVI.

Brief summary: 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.

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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: Reason for screen failure
timeFrame: Baseline
measure: All-cause mortality
timeFrame: 30 days, 1 year, and annually up to 5 years
measure: Hospitalizations
timeFrame: 30 days, 1 year, and annually up to 5 years
measure: Mitral intervention
timeFrame: 30 days, 1 year, and annually up to 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Fort Myers
country: United States
facility: HealthPark Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: West Des Moines
country: United States
facility: MercyOne Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John's Hospital
state: Michigan
city: Mineola
country: United States
facility: NYU Langone Health - Long Island
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Unity Health Toronto; St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: 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;47:72-75. doi: 10.1016/j.carrev.2022.09.003. Epub 2022 Sep 11.
citation: 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.