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

Trial details

Who runs it

University of Parma

Trial code

NCT03143361

Record updated

3 April 2020

Original description

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".Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: Patients undergoing concomitant mitral valve surgery, or tricuspid valve surgery, or aortic surgery (i.e. composite aortic valve and ascending aorta replacement with or without circulatory arrest), or atrial fibrillation surgery, or any other associated cardiac surgical procedure (with the exception of CABG); Concomitant aortic root procedure (i.e. Bentall operation, David operation, homografts, autografts); Percutaneous TAVR requiring surgical cut-down (i.e. failure to comply with a full percutaneous approach, thus configuring a "hybrid procedure"); SAVR with techniques of aortic annular enlargement; Porcelain aorta; Pure aortic valve regurgitation; Patient refusal.

ClinicalTrials.gov NCT03143361