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NCT03488732 Clinical Trial

Valvular Heart Disease Registry

Valvular Heart Disease Clinical Trial

Official title:
Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03488732
Other study ID # V1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2015
Est. completion date January 1, 2030

Study information
Verified date April 2019
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date January 1, 2030
Est. primary completion date January 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcatheter valvular repair or replacement
Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)

Locations
Country Name City State
Germany Klinik für Innere Medizin I München

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality 10 years
Secondary Cardiovascular mortality 10 years
Secondary NYHA status 10 years
Secondary Grade of mitral regurgitation 10 years
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