Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement (CSI-TAVR)

April 25, 2020 updated by: Jochen Wohrle, University of Ulm
To evaluate the long-term results after transcatheter aortic valve replacement

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.

Study Type

Interventional

Enrollment (Actual)

843

Phase

  • Not Applicable

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

  • Germany
      • Ulm, Germany, 89081
        • University of Ulm

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aortic valve stenosis
  • transcatheter aortic valve replacement

Exclusion Criteria:

  • no written 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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: transcatheter aortic valve replacement
Patients receive transcatheter aortic valve replacement.
Device: CE certified transcatheter ( aortic valve replacement)
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cerebral and cardiac events.
Time Frame: 1-5 years
1-5 years

Collaborators and Investigators

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

Sponsor

University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2014

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

June 7, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (ESTIMATE)

June 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 25, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSI TAVR 1.0

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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