Clinical trial NCT06679517: Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
Official title: Studio OsseRvaziOnAle RelatIvo Al Follow-up a LuNGo Termine Di Pazienti Con Stenosi Aortica Severa Valutati Per Sostituzione Valvolare Aortica Percutanea (TAVI).
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Severe Aortic Stenosis
TAVI(Transcatheter Aortic Valve Implantation)
Keywords: severe aortic stenosis
TAVI
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prosthesis failure
timeFrame: 10 years
Secondary outcomes:
measure: composite of all-cause death, stroke and myocardial infarction
timeFrame: 1, 5 and 10 years
measure: all-cause death
timeFrame: 1, 5 and 10 years
measure: myocardial infarction
timeFrame: 1, 5 and 10 years
measure: stroke or transient ischemic attack
timeFrame: 1, 5 and 10 years
measure: atrial fibrillation
timeFrame: 1, 5, 10 years
measure: pacemaker implantation
timeFrame: 1, 5 and 10 years
measure: endocarditis
timeFrame: 1, 5 and 10 years
measure: re-hospitalization
timeFrame: 1,5 and 10 years
measure: prosthesis failure
timeFrame: 1 and 5 years
measure: single component of the primary endpoint
timeFrame: 10 years
measure: incidentalomas
timeFrame: 1, 5 and 10 years
measure: prosthesis failure in patients with incidentaloma
timeFrame: 1 and 5 years
measure: re-TAVI or SVAR in TAVI
timeFrame: 5 and 10 years
measure: coronary revascularization
timeFrame: 1 and 5 years
measure: complication after valvuloplasty pre-TAVI
timeFrame: in-hospital, 1 year
measure: CT predictors of complications post valvuloplasty
timeFrame: 1 year
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
Study officials:
References: