Back to resultsCoronary and Structural Interventions - Transcatheter Aortic Valve Replacement (CSI-TAVR)
Primary Purpose
Aortic Valve Stenosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CE certified transcatheter ( aortic valve replacement)
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility Criteria
Inclusion Criteria:
- aortic valve stenosis
- transcatheter aortic valve replacement
Exclusion Criteria:
- no written informed consent
Sites / Locations
- University of Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
transcatheter aortic valve replacement
Arm Description
Patients receive transcatheter aortic valve replacement.
Outcomes
Primary Outcome Measures
Major adverse cerebral and cardiac events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02162069
Brief Title
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
Acronym
CSI-TAVR
Official Title
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the long-term results after transcatheter aortic valve replacement
Detailed Description
Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
TAVR
Masking
None (Open Label)
Allocation
N/A
Enrollment
843 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transcatheter aortic valve replacement
Arm Type
Experimental
Arm Description
Patients receive transcatheter aortic valve replacement.
Intervention Type
Device
Intervention Name(s)
CE certified transcatheter ( aortic valve replacement)
Intervention Description
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.
Primary Outcome Measure Information:
Title
Major adverse cerebral and cardiac events.
Time Frame
1-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aortic valve stenosis
transcatheter aortic valve replacement
Exclusion Criteria:
no written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Wöhrle, MD
Organizational Affiliation
University of Ulm, Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28917515
Citation
Seeger J, Gonska B, Otto M, Rottbauer W, Wohrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13.
Results Reference
background
PubMed Identifier
30590554
Citation
Seeger J, Kapadia SR, Kodali S, Linke A, Wohrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis. Eur Heart J. 2019 May 1;40(17):1334-1340. doi: 10.1093/eurheartj/ehy847.
Results Reference
result
PubMed Identifier
35576863
Citation
Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.
Results Reference
derived
PubMed Identifier
28643214
Citation
Seeger J, Gonska B, Rottbauer W, Wohrle J. New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome. Cardiovasc Interv Ther. 2018 Jul;33(3):247-255. doi: 10.1007/s12928-017-0477-6. Epub 2017 Jun 22.
Results Reference
derived
PubMed Identifier
28566290
Citation
Seeger J, Gonska B, Rottbauer W, Wohrle J. Outcome With the Repositionable and Retrievable Boston Scientific Lotus Valve Compared With the Balloon-Expandable Edwards Sapien 3 Valve in Patients Undergoing Transfemoral Aortic Valve Replacement. Circ Cardiovasc Interv. 2017 Jun;10(6):e004670. doi: 10.1161/CIRCINTERVENTIONS.116.004670.
Results Reference
derived
PubMed Identifier
27561160
Citation
Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.
Results Reference
derived
PubMed Identifier
27003573
Citation
Wohrle J, Gonska B, Rodewald C, Seeger J, Scharnbeck D, Rottbauer W. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. doi: 10.1371/journal.pone.0151247. eCollection 2016.
Results Reference
derived
Learn more about this trial
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
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