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Enrolling by Invitation

NCT Number: NCT06753227

Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.

The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in the operating room prior to aortic valve implantation. In addition, two catheters (one in the ventricle and one in the aorta) will be used to invasively measure the transvalvular gradient both before and after aortic valve implantation. The invasive measurements will be performed in different positions of the ventricle and aorta simultaneously. At the end of the procedure, aortic gradient measurement by echocardiography shall be performed again. A maximal three months follow-up is expected.

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Key information

Conditions

AORTIC VALVE DISEASES Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis 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

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years and able to give consent
  • Severe symptomatic native aortic valve stenosis with indication for TAVI according to 2021 ESC/EACTS Valvular Heart Disease Guidelines.
  • Use of balloon-expandable THV
  • Written informed consent

Exclusion criteria

  • Emergency or urgent treatment indication
  • Patients under hemodynamically unstable conditions.
  • Previous bioprosthetic aortic valve implantation
  • Patient cannot adhere to or complete the trial protocol for any reason

Treatment and study plan

Primary outcomes

  1. To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient after TAVI.

    Time frame: From enrollment to 3 months

Secondary outcomes

  1. To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient before TAVI.

    Time frame: From enrollment to 3 months

  2. To compare pulse-wave Doppler above the aortic valve before and after TAVI

    Time frame: From enrollment to 3 months

  3. To compare pre-ejection period time pre and post TAVI.

    Time frame: From enrollment to 3 months

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Systematic Assessment of Invasive Versus Echocardiography-derived Transprosthetic Gradients After Transcatheter Aortic Valve Implantation Using Balloon-expandable Transcatheter Heart Valves: the IVEGA-TAVI Study.

Acronym: IVEGA-TAVI

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Dec 31, 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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