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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Valvular Aortic Stenosis Prognosis Study

NCT03628313

Morality

UNKNOWN

Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

NCT02727504

Aortic Valve Stenosis

COMPLETED

Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）

NCT03797820

Valvular Heart Disease

UNKNOWN

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

NCT04613193

Aortic Valve Stenosis Hypertension,Essential Heart Failure

RECRUITING NA

The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis

NCT02856620

Heart Failure Aortic Stenosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe aortic valve stenosis

Simultaneous right and left heart catheterization

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No