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

• Conditions: AORTIC VALVE DISEASES; Aortic Stenosis

• Registration Number: NCT06753227
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 Munich, Bayern, Germany