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

Aortic Valve Stenosis Clinical Trial

— PREFLOW  

Official title:

Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis - a Comparison Between High- and Low Gradient Subtypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580237
• Other study ID #: 1-10-72-71-19
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Simultaneous right and left heart catheterization
Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure and flow relationships across the aortic valve during rest and during supine exercise	Pressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.	2 hours