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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05580237
Acronym
PREFLOW
Enrollment
26
Registered
2022-10-14
Start date
2019-09-01
Completion date
2023-12-01
Last updated
2024-01-03

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

Conditions

Aortic Valve Stenosis

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.

Interventions

PROCEDURESimultaneous 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.

Sponsors

Aarhus University Hospital Skejby
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure and flow relationships across the aortic valve during rest and during supine exercise2 hoursPressure drop across the aortic valve measured invasively. Flow across the valve estimated by right heart catheterization in the absence of aortic valve regurgitation.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026