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

Aarhus University Hospital Skejby

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Simultaneous right and left heart catheterization

Study type: Observational

Funder types: Other

Identifiers

NCT05580237

1-10-72-71-19

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

26 participants in 1 patient group

Severe aortic valve stenosis

Treatment:

Procedure: Simultaneous right and left heart catheterization