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

NCT03143361 | Recruiting DMC

• 1 other identifier: E-AVR
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

aortic valve stenosis; heart valves; heart surgery

Outcome Measures

Primary Outcomes (1)

• 5-year all-cause mortality

  Any death occurring after surgery

  The outcome measure will be assessed at 5 years after surgery

Secondary Outcomes (27)

• Follow-up all-cause mortality

  The outcome measure will be assessed at time point (30 days, and yearly from 1 to 4 years after surgery, then from 6 to 10 years)

• Cardiovascular mortality

  The outcome measure will be assessed at time point (30 days, 1 year, and yearly up to 10 years after surgery

• Stroke

  The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery

• Acute myocardial infarction

  The outcome measure will be assessed at time point (30 days, 1 year, and yearly thereafter up to 10 years after surgery

• Prolonged use of inotropes

  Participants will be followed up to 72 hours after surgery

Other Outcomes (1)

• Quality of Life

  The outcome measure will be assessed at time point (before surgery, at discharge, at 30 days, 6 months, 1 year, and yearly thereafter up to 10 years after surgery

Study Arms (1)

Aortic valve replacement patients

All the patients operated on aortic valve replacement in the study period at all the centers participating in the study

Procedure: Aortic valve replacement

Interventions

Aortic valve replacement PROCEDURE

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

Aortic valve replacement patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred for a surgical treatment of severe aortic valve stenosis (either traditional - through full-sternotomy - or minimally-invasive, or transcatheter - with both "sutured" and "sutureless" valves), isolated or associated with coronary artery bypass grafting

You may qualify if:

• 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

You may not qualify if:

• 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)
• SAVR with techniques of aortic annular enlargement
• Porcelain aorta
• Pure aortic valve regurgitation
• Percutaneous TAVR requiring surgical cut-down (i.e. failure to comply with a full percutaneous approach, thus configuring a "hybrid procedure")
• Patient refusal

Sponsors & Collaborators

• University of Parma: lead
• University of Genova: collaborator
• University Hospitals, Leicester: collaborator
• University of Hamburg-Eppendorf: collaborator
• San Camillo Hospital, Rome: collaborator
• University of Turin, Italy: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• University Hospital, Udine, Italy: collaborator
• Hospital Clinic of Barcelona: collaborator
• University of Lausanne Hospitals: collaborator
• Hopital Universitaire Robert-Debre: collaborator
• Paracelsus Medical University: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University of Texas, Southwestern Medical Center at Dallas: collaborator
• Clinique Pasteur: collaborator
• Cardiocentro Ticino: collaborator
• Universita di Verona: collaborator

Study Sites (1)

University of Verona

Verona, 37126, Italy

RECRUITING

Related Publications (8)

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 RESULT

• Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. doi: 10.1093/eurheartj/ehl428. Epub 2007 Jan 26. No abstract available.

  PMID: 17259184 RESULT

• Filsoufi F, Rahmanian PB, Castillo JG, Chikwe J, Silvay G, Adams DH. Excellent early and late outcomes of aortic valve replacement in people aged 80 and older. J Am Geriatr Soc. 2008 Feb;56(2):255-61. doi: 10.1111/j.1532-5415.2007.01535.x. Epub 2007 Nov 27.

  PMID: 18047491 RESULT

• Grossi EA, Schwartz CF, Yu PJ, Jorde UP, Crooke GA, Grau JB, Ribakove GH, Baumann FG, Ursumanno P, Culliford AT, Colvin SB, Galloway AC. High-risk aortic valve replacement: are the outcomes as bad as predicted? Ann Thorac Surg. 2008 Jan;85(1):102-6; discussion 107. doi: 10.1016/j.athoracsur.2007.05.010.

  PMID: 18154791 RESULT

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 RESULT

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 RESULT

• Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson MJ, Svensson LG; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.

  PMID: 25788234 RESULT

• Onorati F, Gherli R, Mariscalco G, Girdauskas E, Quintana E, Santini F, De Feo M, Sponga S, Tozzi P, Bashir M, Perrotti A, Pappalardo A, Ruggieri VG, Santarpino G, Rinaldi M, Ronaldo S, Nicolini F; E-AVR Collaborators. Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry). BMJ Open. 2018 Feb 10;8(2):e018036. doi: 10.1136/bmjopen-2017-018036.

  PMID: 29440154 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Francesco Onorati, MD, PhD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Onorati, MD, PhD

CONTACT

(+39) 045 812 33 07; francesco.onorati@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiac Surgery

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 8, 2017
• Study Start: November 1, 2017
• Primary Completion: November 30, 2019
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from November 2019 to October 2029
• Access Criteria: The overall anonimyzed datset will be shared among the participants during periodical E-AVR Steering Committee meetings. The entire set of statistical analyses derived from all the approved sub-studies will be available to all E-AVR researchers for the interpretation of data.

Locations

IT (1)