Registry for Aortic Valve Replacement Treatments in Europe
Official title: 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)
Run by University of Parma · NCT03143361 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 8000 (estimated) |
| Sponsor | University of Parma Academic / other |
| Locations | 1 site (Verona) |
| Status | Recruiting |
| Started | November 1, 2017 |
| Main results expected | November 30, 2019 |
| Study ends | October 2029 |
| Registry record updated | April 3, 2020 |
| Trial ID | NCT03143361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown success with similar registry approaches, indicating that real-world data can provide valuable insights into treatment outcomes.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
-
Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
-
CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
-
Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
-
Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
-
How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.