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Recruiting NCT03488732

Valvular Heart Disease Registry

— Observational Valvular Heart Disease

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
The protocol lists: Transcatheter valvular repair or replacement.
Who it may be relevant to
Registry conditions: Valvular Heart 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
Germany
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

Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions

Overview

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.

Interventions

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

Primary outcome measures

  • All-cause mortality [Time frame: 10 years]
Secondary outcome measures (3)
  • Cardiovascular mortality [Time frame: 10 years]
  • NYHA status [Time frame: 10 years]
  • Grade of mitral regurgitation [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

\- Severe valvular defect planned for valvular intervention

Exclusion criteria

\- No informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Klinik für Innere Medizin I — München

Identifiers

NCT: NCT03488732 · V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗