Outcome Comparison of Different Surgical Strategies for the Management of Severe Aortic Valve Stenosis: Study Protocol of a Prospective Multicentre European Registry (E-AVR Registry)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 yy

• Isolated SAVS with or without concomitant aortic valve regurgitation

• Isolated prosthetic aortic dysfunction

• SAVS + coronary artery disease (CAD)

• Prosthetic aortic dysfunction + CAD

• Elective, urgent and emergent procedures

• Endocarditic aetiology

Locations
Other Locations
Italy
University of Verona
RECRUITING
Verona
Contact Information
Primary
Francesco Onorati, MD, PhD
francesco.onorati@univr.it
(+39) 045 812 33 07
Time Frame
Start Date: 2017-11-01
Estimated Completion Date: 2029-10
Participants
Target number of participants: 8000
Treatments
Aortic valve replacement patients
All the patients operated on aortic valve replacement in the study period at all the centers participating in the study
Sponsors
Collaborators: Hospital Clinic of Barcelona, Clinique Pasteur, San Camillo Hospital, Rome, University of Turin, Italy, Hopital Universitaire Robert-Debre, Paracelsus Medical University, Cardiocentro Ticino, Universita di Verona, University of Campania Luigi Vanvitelli, University of Hamburg-Eppendorf, Centre Hospitalier Universitaire de Besancon, University of Genova, University Hospital, Udine, Italy, University of Lausanne Hospitals, University of Texas, Southwestern Medical Center at Dallas, University Hospitals, Leicester
Leads: University of Parma

This content was sourced from clinicaltrials.gov