Recruiting

LF-LG Aortic Stenosis

Sponsor:

Laval University

Code:

NCT01835028

Conditions

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Echocardiography

Computed tomography

Magnetic resonance imaging

Blood biomarkers

Stress echocardiography

Study Details

Brief summary:

Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging encountered in patients with valvular heart disease. Although, CLF-LG AS is recognized has an important clinical entity, current ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management of these patients . PLF-LG AS is a new entity recently described by our group, which is characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a restrictive physiology leading to impaired LV filling, altered myocardial function, and a low-flow state. Up to recently, this entity was often misdiagnosed, leading to underestimation of AS severity and inappropriate delays for aortic valve replacement surgery (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to distinguish between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to accurately quantify the extent of myocardial impairment. Unfortunately, the traditional resting and stress echocardiographic parameters currently used to assess the severity of valvular and myocardial dysfunction in patients with LF-LG AS are far from being optimal, and as a consequence, quantification of disease severity and therapeutic management may not be appropriate in a substantial proportion of these patients.

THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and biomarkers to improve the assessment of stenosis severity and myocardial impairment, the risk-stratification, and the clinical decision making in patients with LF-LG AS and to assess the impact of the different therapeutic strategies on patient outcomes.

Conditions

Aortic Valve Stenosis

Study ID

NCT01835028

Start date

Jun, 2002

Status verified date

Sep, 2021

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • LVEF≤ 40%
  • Indexed aortic valve area (AVA) ≤ 0.6 cm²/m²
  • Mean transvalvular gradient < 40 mmHg

Exclusion criteria:

  • Pregnant or lactating women
  • advanced renal failure
  • tumor with metastasis

Study Design

Enrollment

320 participants

Anticipated

Interventions and Outcome Measures

Arms

Classical Low-Flow, Low-Gradient AS

Observational study in patients with Classical Low-Flow, Low-Gradient Aortic Stenosis and Low LV Ejection Fraction undergoing surgical aortic valve replacement, transcatheter aortic valve replacement, or conservative management:

I- Baseline visit: Medical history, physical / functional evaluation, blood biomarkers, resting echocardiography, stress echocardiography, aortic valve calcium scoring by computed tomography, myocardial fibrosis by magnetic resonance imaging II- Follow-up: clinical outcomes, physical / functional evaluation, echocardiography, blood biomarkers

Paradoxical Low-Flow, Low-Gradient AS

Observational study in patients with Paradoxical Low-Flow, Low-Gradient Aortic Stenosis and Preserved LV Ejection Fraction undergoing surgical aortic valve replacement, transcatheter aortic valve replacement, or conservative management:

I- Baseline visit: Medical history, physical / functional evaluation, blood biomarkers, resting echocardiography, stress echocardiography, aortic valve calcium scoring by computed tomography, myocardial fibrosis by magnetic resonance imaging II- Follow-up: clinical outcomes, physical / functional evaluation, echocardiography, blood biomarkers

Interventions

Echocardiography

Observational Study using Imaging and Biomarkers

Computed tomography

Observational Study using Imaging and Biomarkers

Magnetic resonance imaging

Observational Study using Imaging and Biomarkers

Blood biomarkers

Observational Study using Imaging and Biomarkers

Stress echocardiography

Observational Study using Imaging and Biomarkers

Primary outcome measure

  • all-cause mortality [ Time Frame: Patients will be followed for 5 years, with an average of 3.5 years ]

Central Contacts and Locations

Central contacts

Locations

Ottawa Heart Institute University

Recruiting

Ottawa, Ontario, Canada

Contacts

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Québec, Canada, G1V4G5

Contacts

St Paul's Hospital, Vancouver

Recruiting

Vancouver, Canada

Contacts

More Information

Sponsor

Laval University

Last update posted

Sep 21, 2021

Last verified

Sep, 2021

Keywords

  • Aortic Stenosis
  • Low Flow
  • Low Gradient
  • Left Ventricle
  • Echocardiography, Doppler

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2021-09-21.