Status:
ACTIVE_NOT_RECRUITING
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
Pfizer
Henri Mondor University Hospital
Conditions:
Heart Disease
Aging
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload. Cardiac deposits ...
Detailed Description
Cardiovascular diseases remain the major cause of mortality and morbidity in industrialised countries. Their prevalence increases steeply as consequence of the aging of the population in these countri...
Eligibility Criteria
Inclusion
- Significant aortic stenosis. The aortic stenosis severity (aortic area : \<1cm² or \<0.6cm²/m² measured by echocardiography
- Indication of surgical aortic valve replacement for AS: will be defined in each center in accordance with ESC guidelines.
- Patient ≥ 70 years old and NYHA class ≥2 and LVEF \<60% or global LV strain more than "-17%".
- Written consent prior to surgery.
Exclusion
- Other severe disease with a life prognosis below than 1 year.
- Already known other causes of amyloidosis than senile amyloidosis will be excluded.
- Patients unsuitable for AS surgery as defined by ESC guidelines 2012.
- Significant mitral valve disease needing a surgical treatment.
- Significant aortic regurgitation (class \>III).
- NB: Patients with pacemaker will be included but will not perform the cardiac MRI.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT02260466
Start Date
October 1 2014
End Date
December 31 2024
Last Update
March 13 2024
Active Locations (5)
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1
CHU d'Amiens
Amiens, France
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Chu Rennes
Rennes, France, 35000
4
Centre Cardiologique du Nord
Saint-Denis, France, 93200