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

NCT06679517 | Enrolling By Invitation DMC

• 1 other identifier: 519/2024/Oss/AOUFe
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

severe aortic stenosis; TAVI

Outcome Measures

Primary Outcomes (1)

• Prosthesis failure

  Valve-related mortality OR aortic valve reintervention OR Stage III hemodynamic valve deterioration.

  10 years

Secondary Outcomes (16)

• composite of all-cause death, stroke and myocardial infarction

  1, 5 and 10 years

• all-cause death

  1, 5 and 10 years

• myocardial infarction

  1, 5 and 10 years

• stroke or transient ischemic attack

  1, 5 and 10 years

• atrial fibrillation

  1, 5, 10 years

Study Arms (1)

Patients with aortic stenosis undergoing TAVI

Patients with a diagnosis of severe aortic stenosis candidates to TAVI procedures.

Procedure: TAVI

Interventions

TAVI PROCEDURE

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

Patients with aortic stenosis undergoing TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with a diagnosis of severe aortic stenosis who, since January 2016, have completed all the clinical and instrumental investigations required by the hospital protocol prior to receiving TAVI will be enrolled.

You may qualify if:

• Age \>18 years Signing of the consent form Diagnosis of severe aortic stenosis with an indication for TAVI Completion of the required TAVI pathway exams (ECG and cardiology consultation, echocardiogram, thoraco-abdominal aortic CT angiography, coronary angiography)

You may not qualify if:

• Lack of signed consent form Inability to complete follow-up

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): November 30, 2035
• Study Completion (Estimated): November 30, 2035
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

IT (1)