Status:
UNKNOWN
Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study)
Lead Sponsor:
Laval University
Collaborating Sponsors:
University Hospital, Brest
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
21-90 years
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 amongs...
Detailed Description
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 amongs...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01835028
Start Date
June 1 2002
End Date
January 1 2024
Last Update
September 21 2021
Active Locations (11)
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1
Mayo Clinic
Rochester, Minnesota, United States
2
Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
3
Viena General Hospital
Vienna, Austria
4
CHU Start Tilman
Liège, Belgium