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

Studio OsseRvaziOnAle RelatIvo Al Follow-up a LuNGo Termine Di Pazienti Con Stenosi Aortica Severa Valutati Per Sostituzione Valvolare Aortica Percutanea (TAVI).

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Severe Aortic Stenosis; TAVI(Transcatheter Aortic Valve Implantation)
• Intervention / Treatment: Procedure: TAVI

Detailed Description

DESIGN OF THE STUDY

This is a retrospective and prospective observational, non-profit study. All consecutive patients who have entered the TAVI pathway at this hospital (Azienda Ospedaliera Universitaria di Ferrara) since January 2016 will be included in the study.

The study does not involve any alteration or modification of routine clinical practice and does not require any center or operator to use specific devices.

It involves the collection of pre- and post-procedural data from patients who enter the TAVI pathway.

All patients will be re-contacted to confirm clinical follow-up via telephone to gather information on any adverse events that may have occurred in the years following TAVI (at 1, 5, and 10 years post-TAVI).

For each patient enrolled in the study, an anonymous case report form (CRF) will be completed.

INCLUSION AND EXCLUSION CRITERIA

All patients referred to the valve disease outpatient clinic with a diagnosis of severe aortic stenosis who are candidates for TAVI will be asked to participate in the study and sign the consent form as part of the process to schedule the required investigations.

All consecutive patients with a diagnosis of severe aortic stenosis who, since January 2016, who have completed all the clinical and instrumental investigations required by the hospital protocol prior to receiving TAVI will be enrolled. Therefore, all patients with a diagnosis of severe aortic stenosis who have been indicated for TAVI and have completed the following will be included in the study:

1. Pre-TAVI transthoracic echocardiogram
2. ECG and cardiology consultation to confirm TAVI eligibility
3. Thoraco-abdominal aortic CT angiography
4. Coronary angiography +/- angioplasty +/- valvuloplasty. The decision to perform valvuloplasty or angioplasty prior to TAVI remains at the discretion of the operating physician.

This protocol does not alter clinical judgment or daily routine in any way.

Inclusion criteria:

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)

Exclusion criteria:

Lack of signed consent form Inability to complete follow-up

CONSENT ACQUISITION AND STUDY ENROLLMENT

When a patient meeting the inclusion and exclusion criteria is identified, the investigator or their delegate will explain the study, its procedures, and objectives to the patient. If the patient agrees to participate, they must sign the consent form. The investigator is responsible for keeping a copy of the consent form and providing one to the patient. After consent is signed, all baseline patient characteristics and procedural details will be documented in the designated CRF.

In line with current recommendations for clinical study management, a unique identifier will be assigned to each patient upon creation of the CRF to ensure traceability. Only the investigator will be able to link this identifier to the patient for follow-up purposes. No one other than the center's investigator will have access to identifying patient information in the CRF.

The study also includes a retrospective component, for which patient data will be used in anonymized form. In the retrospective phase, consent will also be obtained for data use, except in cases where patients are deceased or unreachable. In the former case, consent from family members will be sought, while in the latter, the patient will not be included in the study.

The Principal Investigator (PI) or their delegate will collect the following information for each enrolled patient, which will be recorded in the CRF. Documentation of adverse events should be as thorough as possible to enable assessment by the independent adverse event adjudication committee.

ASSESSMENTS PERFORMED IN THE TAVI PATHWAY

As part of standard clinical practice, all patients entering the TAVI pathway will undergo the following:

• Electrocardiogram and cardiology consultation
• Complete transthoracic echocardiogram
• Thoraco-abdominal CT angiography
• Coronary angiography +/- angioplasty +/- valvuloplasty

PROSTHESIS IMPLANTATION INFORMATION

During the TAVI hospitalization, the following clinical information will be collected for each enrolled patient:

Type of implanted prosthesis Procedural details (fluoroscopy time, amount of contrast media, use of temporary pacemaker) Information on any procedural or post-procedural complications according to VARC criteria (see subsequent definitions) POST-TAVI ASSESSMENTS

Following TAVI, as per routine practice, patients will undergo the following evaluations before discharge (at our hospital in case of in-service procedures or at the TAVI-performing center):

Electrocardiogram Transthoracic echocardiogram Clinical assessment to rule out post-procedural complications

CLINICAL FOLLOW-UP

All TAVI patients are routinely re-evaluated 1-3 months post-procedure at the Valve Disease outpatient clinic, where they receive:

Clinical assessment Electrocardiogram Transthoracic echocardiogram

TELEPHONE FOLLOW-UP All patients enrolled in the study will be contacted by telephone at 1, 5, and 10 years post-TAVI to gather information on any adverse events that may have occurred during the follow-up period.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Azienda Ospedaliero Universitaria di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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)

Exclusion Criteria:

Lack of signed consent form Inability to complete follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with aortic stenosis undergoing TAVI; Patients with a diagnosis of severe aortic stenosis candidates to TAVI procedures.	Procedure: TAVI; Clinical follow-up up to 10 years of patients undergoing TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosthesis failure	Valve-related mortality OR aortic valve reintervention OR Stage III hemodynamic valve deterioration.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite of all-cause death, stroke and myocardial infarction	composite of all-cause death, stroke and myocardial infarction	1, 5 and 10 years
all-cause death	all-cause death	1, 5 and 10 years
myocardial infarction	myocardial infarction	1, 5 and 10 years
stroke or transient ischemic attack	Any new cerebrovascular accident	1, 5 and 10 years
atrial fibrillation	new onset atrial fibrillation	1, 5, 10 years
pacemaker implantation	pacemaker implantation after the TAVI procedure	1, 5 and 10 years
endocarditis	endocarditis of the TAVI	1, 5 and 10 years
re-hospitalization	new all-cause hospitalization after TAVI	1,5 and 10 years
prosthesis failure	Valve-related mortality OR aortic valve reintervention OR Stage III hemodynamic valve deterioration.	1 and 5 years
single component of the primary endpoint	Valve-related mortality OR aortic valve reintervention OR Stage III hemodynamic valve deterioration.	10 years
incidentalomas	rate of incidentalomas at the TAVI pre-screening exams	1, 5 and 10 years
prosthesis failure in patients with incidentaloma	occurrence of prothesis failure in patients with incidentaloma	1 and 5 years
re-TAVI or SVAR in TAVI	Occurence of re-intervention with TAVI or surgically in patients treated with TAVI	5 and 10 years
coronary revascularization	new coronary revascularization after TAVI	1 and 5 years
complication after valvuloplasty pre-TAVI	occurrence of any complication following aortic valvuloplasty pre-TAVI	in-hospital, 1 year
CT predictors of complications post valvuloplasty	Presence of predictors of complications related to valvuloplasty on CT scan	1 year

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Estimated): November 30, 2035
• Study Completion (Estimated): November 30, 2035

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: severe aortic stenosis; TAVI
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 519/2024/Oss/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No