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The Leipzig TAVI Registry

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05015452
Enrollment
20000
Registered
2021-08-20
Start date
2020-03-01
Completion date
2030-12-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

DEVICETranscatheter Aortic Valve Implantation

Interventional replacement of the aortic valve

Sponsors

Helios Health Institute GmbH
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* All patients treated with TAVI

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
MortalityUp to 10 yearsCardiovascular 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

MeasureTime frameDescription
Structural valve deteriorationUp to 10 yearsTransposthetic mean pressure gradient ≥ 40mmHg and/or ≥20mmHg rise from baseline OR severe intraprosthetic aortic regurgitation

Countries

Germany

Contacts

Primary ContactMohamed Abdel-Wahab, MD
mohamed.bdel-wahab@medizin.uni-leipzig.de+49 341 865 1428
Backup ContactHolger Thiele, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026