Valvular Heart Disease Registry

April 9, 2019 updated by: Technical University of Munich

Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing transcatheter valvular interventions

Description

Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergonig transcatheter valvular 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular mortality
Time Frame: 10 years
10 years
NYHA status
Time Frame: 10 years
10 years
Grade of mitral regurgitation
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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