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NCT05015452 Clinical Trial

The Leipzig TAVI Registry

Aortic Valve Stenosis Clinical Trial

Official title:
An Observational Follow-up Assessment of Transcatheter Aortic Valve Implantation in Leipzig

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05015452
Other study ID # 2020-0089
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date December 31, 2030

Study information
Verified date September 2023
Source Helios Health Institute GmbH
Contact Mohamed Abdel-Wahab, MD
Phone +49 341 865 1428
Email mohamed.bdel-wahab@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany

Description:

A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.

Recruitment information / eligibility
Status Recruiting
Enrollment 20000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients treated with TAVI Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcatheter Aortic Valve Implantation
Interventional replacement of the aortic valve

Locations
Country Name City State
Germany Herzzentrum Leipzig Leipzig

Sponsors (1)
Lead Sponsor Collaborator
Helios Health Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Cardiovascular and not cardiovascular death
identify the current incidence of periprocedural complications.
identification of risk groups
description of the long-term outcome with special attention to the durability of the different prostheses		 Up to 10 years
Secondary Structural valve deterioration Transposthetic mean pressure gradient = 40mmHg and/or =20mmHg rise from baseline OR severe intraprosthetic aortic regurgitation Up to 10 years
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