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Recruiting NCT05015452

The Leipzig TAVI Registry

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Aortic Valve Implantation.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Transcatheter Aortic Valve Implantation
    Interventional replacement of the aortic valve

Primary outcome measures

  • Mortality [Time frame: Up to 10 years]
Secondary outcome measures (1)
  • Structural valve deterioration [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

  • All patients treated with TAVI

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Herzzentrum Leipzig — Leipzig

Publications

  • Abdelhafez A, Lankisch N, Iannopollo G, Dumpies O, Rotta Detto Loria J, Richter I, Majunke N, Feistritzer HJ, Gohmann R, Desch S, Noack T, Thiele H, Abdel-Wahab M. CT-Based Risk Stratification of Coronary Obstruction During TAVR: Clinical Utility and a New Volumetric Parameter. JACC Cardiovasc Interv. 2026 Jun 8;19(11):1406-1419. doi: 10.1016/j.jcin.2026.04.015. PMID 42264632
  • Abdel-Wahab M, Kitamura M, Fitzgerald SJ, Dumpies O, Wilde J, Gohmann RF, Majunke N, Gutberlet M, Kiefer P, Noack T, Lurz P, Desch S, Frawley C, Ward K, Borger MA, Holzhey D, Thiele H. Neo-Commissural Alignment Technique for Transcatheter Aortic Valve Replacement Using the ACURATE Neo Valve. Circ Cardiovasc Interv. 2022 Jul;15(7):e011993. doi: 10.1161/CIRCINTERVENTIONS.122.011993. Epub 2022 Jul 1. PMID 35775417

Identifiers

NCT: NCT05015452 · 2020-0089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗