Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
The EffecTAVI Registry is a clinical trial that is studying the safety and effectiveness of a procedure called Transcatheter Aortic Valve Replacement (TAVI) for patients with severe aortic stenosis (AS), which is a narrowing of the heart valve that can cause serious health problems. This trial is important because TAVI is a less invasive option compared to traditional surgery, and it has been shown to be just as effective or even better in many cases. The study is currently looking for participants who are experiencing symptoms of severe AS or have a replaced valve that is not working well and are considered suitable for TAVI after a thorough evaluation by a team of heart specialists.
To be eligible for this study, participants need to be able to provide informed consent and should have symptoms related to severe AS. Those who have certain health issues that could make TAVI unsafe, or who may struggle to follow study instructions, will not be included. If you join the trial, you can expect to receive close monitoring and care throughout the process, contributing to important research that could help improve treatment options for others in the future.
Gender
ALL
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.
About Federico Ii University
Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Naples, , Italy
Patients applied
Trial Officials
Giovanni Esposito, MD, PhD
Principal Investigator
Federico II University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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