Early Surgery for Patients With Asymptomatic Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Combination of overall mortality and cardiac morbidity
- Last Updated
- 8 years ago
Overview
Brief Summary
Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Combination of overall mortality and cardiac morbidity
Time Frame: 1 year after randomization.
Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death.
Secondary Outcomes
- Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity(1 year after randomization)
- Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group(assessed at 3 months after surgery)
- Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group(assessed at 3 months after surgery)
- Postoperative Exercise test (Exercise Electrocardiogram)(assessed at 3 months after surgery)