Registry for Aortic Valve Replacement Treatments in Europe
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)
University of Parma · NCT03143361
This study is collecting data from patients in Europe to see how well different surgical treatments for severe aortic valve stenosis work and how they affect quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Parma (other) |
| Locations | 1 site (Verona) |
| Trial ID | NCT03143361 on ClinicalTrials.gov |
What this trial studies
This study aims to collect real-world data on the safety and efficacy of various surgical treatments for severe aortic valve stenosis (SAVS), including traditional surgery and transcatheter approaches. By enrolling patients from multiple centers across Europe, the registry will provide insights into outcomes and quality of life associated with different surgical techniques. The study will include a diverse patient population with varying surgical risks and will focus on both short-term and long-term results. This approach allows for a comprehensive understanding of treatment impacts beyond the limitations of randomized controlled trials.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with isolated severe aortic valve stenosis, with or without concurrent coronary artery disease.
Not a fit: Patients undergoing other cardiac surgeries or those with specific contraindications, such as pure aortic valve regurgitation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment decision-making for patients with aortic valve stenosis by providing robust data on the effectiveness of different surgical options.
How similar studies have performed: Previous studies have shown success with similar registry approaches, indicating that real-world data can provide valuable insights into treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Verona
- University of Verona — Verona, Italy (RECRUITING)
Study contacts
- Principal investigator: Francesco Onorati, MD, PhD — Universita di Verona
- Study coordinator: Francesco Onorati, MD, PhD
- Email: francesco.onorati@univr.it
- Phone: (+39) 045 812 33 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, Valve Heart Stenosis, aortic valve stenosis, heart valves, heart surgery