Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)

Summary

Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy. Recent randomized trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared to traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the "real clinical world".

Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample-size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full-sternotomy; minimally-invasive; or transcatheter; with both "sutured" and "sutureless" valves) will provide a "real-world" picture of available results of current surgical options, and will help to clarify the "grey zones" of current guidelines.

E-AVR is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery Centres located in six countries (France, Germany, Italy, Spain, Switzerland, and United Kingdom). Patients will be enrolled over a 2-year period and followed-up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with VARC-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing "early" 30-day all-cause and cardiovascular mortality, as well as major morbidity, and "late" cardio-vascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.

The study protocol is approved by Local Ethics Committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE) for authorship.

Conditions

• Aortic Valve Stenosis
• Valve Heart Stenosis

Interventions

PROCEDURE

Aortic valve replacement

All surgical procedures used for both traditional and mini-invasive aortic valve replacement, as well as transcatheter valve implantation.

Sponsors & Collaborators

• University of Genova

  collaborator OTHER

• University Hospitals, Leicester

  collaborator OTHER

• University of Hamburg-Eppendorf

  collaborator OTHER

• San Camillo Hospital, Rome

  collaborator OTHER

• University of Turin, Italy

  collaborator OTHER

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• University Hospital, Udine, Italy

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Hopital Universitaire Robert-Debre

  collaborator OTHER

• Paracelsus Medical University

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• University of Texas, Southwestern Medical Center at Dallas

  collaborator OTHER

• Clinique Pasteur

  collaborator OTHER

• Cardiocentro Ticino

  collaborator OTHER

• Universita di Verona

  collaborator OTHER

• University of Parma

  lead OTHER

Principal Investigators

• Francesco Onorati, MD, PhD · Universita di Verona

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2019-11-30

Completion

2029-10-31

Countries

• Italy

Study Locations