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

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ClinicalTrials.gov Identifier: NCT02162069
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm

Brief Summary:
To evaluate the long-term results after transcatheter aortic valve replacement

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: CE certified transcatheter ( aortic valve replacement) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: TAVR
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions Ulm - Transcatheter Aortic Valve Replacement
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Major adverse cerebral and cardiac events. [ Time Frame: 1-5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aortic valve stenosis
  • transcatheter aortic valve replacement

Exclusion Criteria:

  • no written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162069


Contacts
Contact: Jochen Wöhrle, MD +49 731 500 ext 45047 jochen.woehrle@uniklinik-ulm.de

Locations
Germany
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Jochen Wöhrle, MD    ++49 731 500 ext 45047    jochen.woehrle@uniklinik-ulm.de   
Principal Investigator: Jochen Wöhrle, MD         
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Jochen Wöhrle, MD University of Ulm, Ulm, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT02162069     History of Changes
Other Study ID Numbers: CSI Ulm TAVR 1.0
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction