Registry for patients undergoing Transcatheter Aortic Valve Replacement
Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
This study is tracking patients with severe aortic stenosis who are having a new heart valve procedure called TAVI to see how safe and effective it is for their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05235555 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) in patients with symptomatic severe aortic stenosis. It will collect clinical, procedural, and echocardiographic data to assess the clinical outcomes of the TAVI procedure. The study is conducted at the Federico II University in Naples and focuses on patients deemed suitable for TAVI by a multidisciplinary team. The findings will contribute to understanding the impact of TAVI on patient health and outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic severe aortic stenosis who are suitable for TAVI as determined by a Heart Team evaluation.
Not a fit: Patients with contraindications to TAVI or those unable to adhere to follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of TAVI's effectiveness and safety, potentially improving treatment options for patients with aortic stenosis.
How similar studies have performed: Previous studies have shown success with TAVI, establishing it as a viable alternative to surgical aortic valve replacement.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation; 2. Ability to provide informed consent. Exclusion Criteria: 1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis; 2. Poor adherence to scheduled follow-up; 3. Unable to understand and follow study-related instructions.
Where this trial is running
Naples
- Federico II University of Naples — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni Esposito, MD, PhD — Federico II University
- Study coordinator: Giovanni Esposito, MD, PhD
- Email: espogiov@unina.it
- Phone: +390817463075
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.