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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162069
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : April 28, 2020
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 843 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: TAVR
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
Study Start Date : June 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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


Locations
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Germany
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Jochen Wöhrle, MD University of Ulm, Ulm, Germany
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT02162069    
Other Study ID Numbers: CSI TAVR 1.0
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction