Brief Title
Early Surgery for Patients With Asymptomatic Aortic Stenosis
Official Title
Early Surgery for Patients With Asymptomatic Aortic Stenosis
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.
Study Type
Interventional
Primary Outcome
Combination of overall mortality and cardiac morbidity
Secondary Outcome
Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity
Condition
Aortic Valve Stenosis
Intervention
Early surgical aortic valve replacement
Study Arms / Comparison Groups
Early surgery
Description: Surgical aortic valve replacement
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
360
Start Date
January 2016
Completion Date
November 2019
Primary Completion Date
November 2018
Eligibility Criteria
Inclusion criteria - Adult patient, aged between 18 and 80 years (18 ≤ age ≤80) - Low operative risk, defined as EuroSCORE II ≤ 5% - No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise - No class I indication for surgery - No symptom/ fall in blood pressure during exercise test - Severe AS according to current echocardiography criteria: Vmax > 4.0 m/s and/ or MPG > 40 mm Hg); AVA < 1.0 cm2 (not mandatory) - Preserved LV systolic function: LVEF >50% according to echocardiography ; no LV wall motion abnormality - Signed informed consent Exclusion criteria - Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II > 5% - Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa) - Other indication for cardiac surgery (CABG, thoracic aorta) - Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value. - Patients unable to perform the exercise ECG - More than mild AR (>grade 2/4)/ other significant valve disease LVEF ≤ 50% - Serum creatinine >160 μmol/L - Serious extra cardiac comorbidity/ life expectancy <2 years - Patient included in another trial with signed informed consent - Patient not affiliated to social insurance - Pregnancy
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Jean-Luc MONIN, MD PhD., (0)1 49 81 28 10, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02627391
Organization ID
AOM 140460
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Jean-Luc MONIN, MD PhD., Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
June 2017