CSI-TAVR: Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT02162069
• Collaborator: (none)
• Enrollment: 843
• Location: 1
• Arm: 1
• Duration (Months): 54
• Patients Per Site Per Month: 15.6

Study Details

Study Description

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)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 843 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: TAVRTAVR
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Major adverse cerebral and cardiac events. [1-5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• aortic valve stenosis

• transcatheter aortic valve replacement

Exclusion Criteria:

• no written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ulm	Ulm		Germany	89081

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Jochen Wöhrle, MD, University of Ulm, Ulm, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• Seeger J, Gonska B, Otto M, Rottbauer W, Wöhrle 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.

• 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: Jun 12, 2014
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Apr 28, 2020