| NCT ID | NCT05235555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2015-09-01 |
| Primary Completion | 2021-09-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2015-09-01 with a primary completion date of 2021-09-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears. For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time. This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
Eligibility 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.
Contact & Investigator
Giovanni Esposito, MD, PhD
PRINCIPAL INVESTIGATOR
Federico II University
Frequently Asked Questions
Who can join the NCT05235555 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 100 Years, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05235555 currently recruiting?
Yes, NCT05235555 is actively recruiting participants. Contact the research team at espogiov@unina.it for enrollment information.
Where is the NCT05235555 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT05235555 clinical trial?
NCT05235555 is sponsored by Federico II University. The principal investigator is Giovanni Esposito, MD, PhD at Federico II University. The trial plans to enroll 1,000 participants.