MedTrace Logo

Early Surgery for Patients With Asymptomatic Aortic Stenosis

NCT02627391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-07-05

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Surgery

Interventions

OTHER

Early surgical aortic valve replacement

OTHER

Delayed Surgical aortic valve replacement

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Luc MONIN, MD PhD. · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-11-30
Completion
2019-11-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627391 on ClinicalTrials.gov