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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06753227

Acronym

IVEGA-TAVI

Enrollment

250

Registered

2024-12-31

Start date

2024-05-28

Completion date

2026-05-31

Last updated

2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, AORTIC VALVE DISEASES

Keywords

invasive gradients, haemodynamics, aortic valve stenosis, echocardiographic gradients

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient after TAVI.	From enrollment to 3 months

Secondary

Measure	Time frame
To compare transvalvular echocardiographic aortic mean vs. invasive aortic mean gradient before TAVI.	From enrollment to 3 months
To compare pulse-wave Doppler above the aortic valve before and after TAVI	From enrollment to 3 months
To compare pre-ejection period time pre and post TAVI.	From enrollment to 3 months

Countries

Germany

Outcome results