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Completed

NCT Number: NCT02289339

Everyday Practice With Transcatheter Aortic Valve Implantation

The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Department, Segeberger Kliniken, Bad Segeberg, Germany

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About this study

The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aortic stenosis
  • Intermediate-to-high risk for surgery
  • Heart team decision

Exclusion criteria

  • Contraindication to transfemoral TAVI procedure

Treatment and study plan

aortic valve prostheses

Device

balloon-expandable and self-expandable aortic valve prostheses

Other names: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus

Primary outcomes

  1. incidence of post-TAVI aortic regurgitation

    Time frame: 30 days

    echocardiographicall and angiographycally determined

Secondary outcomes

  1. incidence of bleeding complications

    Time frame: 30 days

    defined according to BARC and VARC-2 classification

  2. mortality

    Time frame: 30 days

    all-cause and cardio/cerebrovascular death

  3. mortality rate

    Time frame: 2-years

    all-cause and cardio/cerebrovascular death

  4. mortality rate

    Time frame: 5-years

    all-cause and cardio/cerebrovascular death

  5. incidence of cerebrovascular events

    Time frame: 30 days

    stroke or TIA

  6. incidence of cerebrovascular events

    Time frame: 2-years

    stroke or TIA

  7. incidence of cerebrovascular events

    Time frame: 5-years

    stroke or TIA

  8. incidence of new pacemaker implantation

    Time frame: 30-day

    pacemaker after TAVI

  9. incidence of new pacemaker implantation

    Time frame: 1-year

    pacemaker after TAVI

Other outcomes

  1. incidence of vascular complications

    Time frame: 30 days

    defined according to VARC-2 classification

  2. incidence of re-hospitalisation

    Time frame: 2-year

    new unplanned hospital stay due to cardiovascular und cerebrovascular reasons

  3. incidence of re-hospitalisation

    Time frame: 5-year

    new unplanned hospital stay due to cardiovascular und cerebrovascular reasons

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study title

Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers

Acronym: EVERY-TAVI

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2014
Registry last updated
Aug 13, 2018

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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