Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement
Completed
- Conditions
- Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement
- Registration Number
- NCT03686527
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
Inclusion Criteria
- major patient freely accepting to participate in the study
- non-opposition signed
- aortic surface <1cm² or <0.6cm² / m² of indication surgical restraint
- oriented to short interventional management surgical term
- LVEF Left ventricular ejection fraction> 50%
- In the subgroup "MRI-fibrosis", absence of indication for performing MRI
Exclusion Criteria
- patient under guardianship, curatorship or safeguard of justice
- minor patient
- pregnant woman
- patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
- patient with severe coronary artery disease requiring revascularization
- allergy to the contrast product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement. 1 day of inclusion
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link aortic stenosis to myocardial dysfunction in NCT03686527?
How does Setonis Aortic Valve replacement compare to standard surgical valves in terms of myocardial recovery outcomes?
Which biomarkers correlate with improved prognosis after Setonis Aortic Valve implantation in aortic stenosis patients?
What are the potential adverse events associated with Setonis Aortic Valve and how are they managed?
Are there combination therapies or competitor devices that enhance myocardial function in aortic stenosis beyond valve replacement?
Trial Locations
- Locations (1)
CHU Rennes
🇫🇷Rennes, Bretagne, France
CHU Rennes🇫🇷Rennes, Bretagne, France