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

Study acronym: IVEGA-TAVI
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record status
This record was last updated December 31, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06753227
Lead Sponsor Deutsches Herzzentrum Muenchen
Collaborators: Edwards Lifesciences
Conditions
(from sponsor)		 AORTIC VALVE DISEASES, Aortic Stenosis
Related terms Aortic Valve Disease, Aortic Valve Stenosis
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov