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EffecTAVI Registry

Launched by FEDERICO II UNIVERSITY · Feb 8, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Aortic Stenosis Transcatheter Aortic Valve Replacement Tavi

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.

Locations

Naples, , Italy

Patients applied

0 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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