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Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).

NCT06679517 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-03-27

No results posted yet for this study

Summary

All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments:

* Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical assessment, ECG, and laboratory tests.
* Post-implantation: echocardiography, laboratory tests, ECG, assessment of any procedural complications, and a cardiology follow-up visit.

This is an observational study, with the aim to monitor over time the population of patients who have undergone TAVI, identifying pre- and post-implant conditions that may negatively impact patient outcomes (both clinical factors and those directly related to the prosthetic implant). Through a 10-year follow-up, the study seeks to determine the incidence of prosthetic failure, as well as the incidence of prosthesis-related complications and major clinical endpoints.

Conditions

  • Severe Aortic Stenosis
  • TAVI(Transcatheter Aortic Valve Implantation)

Interventions

PROCEDURE

TAVI

Clinical follow-up up to 10 years of patients undergoing TAVI

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2035-11-30
Completion
2035-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679517 on ClinicalTrials.gov