NCT05015452

The Leipzig TAVI Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Helios Health Institute GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation	Interventional replacement of the aortic valve

Timeline

• Start date: 2020-03-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2021-08-20
• Last updated: 2024-10-09

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study