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

NCT06753227 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-12-31

No results posted yet for this study

Summary

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.

Conditions

  • AORTIC VALVE DISEASES
  • Aortic Stenosis

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Michael Joner, Professor Dr. med. · Deutsches Herzzentrum München

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753227 on ClinicalTrials.gov