The Leipzig TAVI Registry

Recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT05015452
• Lead Sponsor: Helios Health Institute GmbH

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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; 1. identify the current incidence of periprocedural complications.; 2. identification of risk groups; 3. description of the long-term outcome with special attention to the durability of the different prostheses

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany