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Completed

NCT Number: NCT05580237

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simultaneous right and left heart catheterization

Procedure

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

Primary outcomes

  1. Pressure and flow relationships across the aortic valve during rest and during supine exercise

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

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

Acronym: PREFLOW

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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