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NCT03192774 Clinical Trial

The Prospective Segeberg TAVI Registry

Aortic Valve Stenosis Clinical Trial

— POST-TAVI  

Official title:
A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03192774
Other study ID # SK 109 -- 168/11
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2007
Est. completion date December 2032

Study information
Verified date June 2022
Source Segeberger Kliniken GmbH
Contact Mohamed Abdel-Wahab, MD
Email msabdelwahab@gmail.com
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, Bad Segeberg, Germany

Description:

A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2032
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
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 Heart Center, Segeberger Kliniken Bad Segeberg

Sponsors (1)
Lead Sponsor Collaborator
Segeberger Kliniken GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Cardiovascular and not cardiovascular death Up to 10 years
Secondary Structural valve deterioration Transprosthetic mean pressure gradient =40 mmHg and/or =20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation Up to 10 years
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