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MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.
NCT07612553
Mitral Annular Calcification, Mitral Valve Disease
Milan, Italy
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NCT Number: NCT04736667
Mitral Valve Screening Survey
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).
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Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
St. Paul's Hospital, Vancouver, British Columbia, Canada
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
All-cause mortality
Time frame: 1 year
Secondary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Jake Sutton
CONTACT
Kassandra Lopez
CONTACT
Sponsors and collaborators
Lead sponsor
Medstar Health Research Institute
Other
Registry information
Official study title
Mitral Valve Screening Survey (MVSS)
Acronym: MVSS
Important dates
- Study start
- 2021
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 3, 2021
- Registry last updated
- Aug 29, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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