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

Launched by UNIVERSITY OF PARMA · May 3, 2017

Keywords

ClinConnect Summary

The E-AVR Registry is a clinical trial studying different ways to treat severe aortic valve stenosis (SAVS), a condition where the heart's aortic valve doesn't open properly, making it harder for blood to flow. This trial aims to gather real-world data on various treatment options, including traditional surgery and newer minimally invasive methods. Researchers want to understand how these treatments work in everyday clinical settings, rather than just in controlled trials.

To participate in this study, you need to be over 18 years old and have SAVS, with or without other heart conditions. The trial is open to patients from 16 hospitals across six European countries. If you join, you’ll be monitored for 5 to 10 years after your treatment to see how well the procedures work and how they affect your health and quality of life. This research is important because it will help doctors make better decisions about the best treatments for patients with SAVS.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 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 criteria
• • 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