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Recruiting

NCT Number: NCT05015452

The Leipzig TAVI Registry

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

Recruiting

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Leipzig

Leipzig, Germany

Location status: Recruiting

Location contact

Mohamed Abdel-Wahab, MD

CONTACT

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients treated with TAVI

Exclusion criteria

  • None

Treatment and study plan

Transcatheter aortic valve implantation

Device

Interventional replacement of the aortic valve

Primary outcomes

  1. Mortality

    Time frame: Up to 10 years

    Cardiovascular and not cardiovascular death

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

Secondary outcomes

  1. Structural valve deterioration

    Time frame: Up to 10 years

    Transposthetic mean pressure gradient ≥ 40mmHg and/or ≥20mmHg rise from baseline OR severe intraprosthetic aortic regurgitation

Study contacts

Contact information is provided by the study sponsor or research team.

Holger Thiele, MD

CONTACT

Mohamed Abdel-Wahab, MD

CONTACT

[email protected]

+49 341 865 1428

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Aug 20, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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