The Prospective Segeberg TAVI Registry

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03192774
• Lead Sponsor: Segeberger Kliniken GmbH

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-18
• Study First Posted: 2017-06-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• All patients treated with TAVI

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 10 years	Cardiovascular and not cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Structural valve deterioration	Up to 10 years	Transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation

Trial Locations

Locations (1)

Heart Center, Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany