Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.
Key facts
- Where
- Munich, GermanySee the site
Where in Germany
- Deutsches Herzzentrum MünchenMunich, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Deutsches Herzzentrum Muenchen
- Trial code
- NCT06753227
- Record updated
- 31 December 2024
- Original description
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.Read full original descriptionShow less
Systematic Assessment of Invasive Versus Echocardiography-derived Transprosthetic Gradients After Transcatheter Aortic Valve Implantation Using Balloon-expandable Transcatheter Heart Valves: the IVEGA-TAVI Study.
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.
Inclusion: 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: Previous bioprosthetic aortic valve implantation; Patients under hemodynamically unstable conditions; Emergency or urgent treatment indication; Patient cannot adhere to or complete the trial protocol for any reason.