Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: Simultaneous right and left heart catheterization

• Registration Number: NCT05580237
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
• LVEF > 50 %
• AVA < 1.0 cm2
• Symptomatic - at least equivalent to NYHA functional class II

Exclusion Criteria

• Congenital heart disease
• Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
• Moderate or severe aortic valve regurgitation
• Moderate or severe mitral valve regurgitation or stenosis
• Moderate or severe pulmonary valve regurgitation or stenosis
• Moderate or severe tricuspid valve regurgitation or stenosis
• Severe pulmonary hypertension (tricuspid valve pressure gradient of 60 mmHg)
• Right ventricular dysfunction (TAPSE < 17 mm)
• Restrictive cardiomyopathy or cardiac amyloidosis
• Constrictive pericarditis
• Inability to perform supine bicycle exercise

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe aortic valve stenosis	Simultaneous right and left heart catheterization	-

Primary Outcome Measures

Name	Time	Method
Pressure and flow relationships across the aortic valve during rest and during supine exercise	2 hours	Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark