Early Surgery for Patients With Asymptomatic Aortic Stenosis

Not Applicable

• Conditions: Aortic Valve Surgery; Aortic Valve Stenosis
• Interventions: Other: Early surgical aortic valve replacement; Other: Delayed Surgical aortic valve replacement

• Registration Number: NCT02627391
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-10
• Study Start: 2016-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05
• Primary Completion: 2018-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early surgery	Early surgical aortic valve replacement	Surgical aortic valve replacement
Delayed surgery according to guidelines	Delayed Surgical aortic valve replacement	Surgical aortic valve replacement

Primary Outcome Measures

Name	Time	Method
Combination of overall mortality and cardiac morbidity	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France