Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement. (ARDITAV)

January 23, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Progression of the Ascending Aorta Diameter After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve.

The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022.

Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bicuspid aortic valve (BAV) is the most common congenital heart defect in adults, affecting 1.3% of the population worldwide. Although valve dysfunction is the most common complication of a bicuspid aortic valve, there is evidence of association of BAV with a specific disease pathology involving the aorta called bicuspid aortopathy. This condition has been proved to predispose to dilatation of all the segments of the proximal aorta both on a genetic and a hemodynamic base, with a reported prevalence of approximately 50% of patients with BAV. Aortic dissection is therefore the most feared complication of BAV aortopathy and BAV itself, but despite a higher relative risk that increases with age, the absolute incidence of aortic dissection remains low.

In elderly population the prevalence of BAV seems to be relatively high as well (incidence of 22% in a reported cohort of octogenarian patients). In the era of transcatheter aortic valve replacement (TAVR), the knowledge of BAV incidence in the elderly is extremely important, assuming that this condition has been considered for years a contraindication to percutaneous procedure by the most. Nevertheless, TAVR has been proved to be a feasible and safe procedure in specific patients deemed at high surgical risk.

As BAV dysfunction tends to reveal earlier than tricuspid ones, when patients are referred to surgery for aortic valve replacement, ascending aorta is often still normal-sized, not deserving surgical treatment, according to current guidelines. It remains controversial whether there is need for concomitant aortic surgery among patients with BAV dysfunction and moderately-dilated aorta, as some authors reported progressive aortic dilatation and aortic dissection even after AVR.

So far, it has never been investigated and there is no information regarding possible differences in the rate of aneurysmal progression in patients with bicuspid aortic valve undergoing surgical or percutaneous aortic valve replacement. A follow-up Computed Tomography (CT) scan is therefore indicated in these patients as chest CT scan is the gold standard for the exact measurement of the aortic diameters.

Aim of this prospective, non-randomized observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement using CT and echocardiographic imaging in patients with a stenotic BAV who undergo surgical or transcatheter aortic valve replacement.

At the moment no data are available to formulate any hypothesis. Based on our selection criteria a sample size of 150 will be considered in this study, 60% submitted to a surgical approach and 40% to a transcatheter replacement. This sample size is able to detect, in term of effect size, a difference in diameters changes between the 2 procedures from baseline to approximatively 90 days after procedure of about 0.45, considering a significance level of 5% and a power of 80%.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Agostino Gemelli
        • Principal Investigator:
          • Giovanni A Chiariello, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with bicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement and concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Bicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement;
  • Concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention;
  • Patients with indication to follow-up Chest CT angiography Scan.
  • Signed informed consent, inclusive of release of medical information.

Exclusion Criteria:

  • Aortic valve replacement in tricuspid valves or bicuspid insufficient valves or endocarditis;
  • Aortic valve replacement associated with surgery of ascending aorta/aortic root;
  • Aortic valve replacement associated with other cardiac valve surgery;
  • Previous cardiac surgery of any kind;
  • Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
  • Participation in another clinical trial that could interfere with the endpoints of this study;
  • Pregnant or breastfeeding at time of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical Aortic Valve Replacement (SAVR)
Patients who undergo surgical aortic valve replacement through median longitudinal sternotomy.
Diagnostic test: Echocardiographic assessment.
Patients will be contacted to carry out an echocardiography at least 90 days after surgery. Measurements will be taken for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta. Aortic valve will be assessed as well.
Diagnostic test: Computed-tomography assessment
All enrolled patients will undergo a multislice CT scan (retrospectively ECG-gated, whenever possible) with standard contrast medium injection protocol of nonionic contrast agent. All post-surgery controls will be performed at least 90 days after surgery. All CT datasets will be analysed on a dedicated workstation for the qualitative and quantitative assessment of the aortic root including measurements for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta.
Other Names:
  • CT scan
Transcatheter Aortic Valve Replacement (TAVR)
Patients who undergo transcatheter aortic valve replacement through a transfemoral access.
Diagnostic test: Echocardiographic assessment.
Patients will be contacted to carry out an echocardiography at least 90 days after surgery. Measurements will be taken for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta. Aortic valve will be assessed as well.
Diagnostic test: Computed-tomography assessment
All enrolled patients will undergo a multislice CT scan (retrospectively ECG-gated, whenever possible) with standard contrast medium injection protocol of nonionic contrast agent. All post-surgery controls will be performed at least 90 days after surgery. All CT datasets will be analysed on a dedicated workstation for the qualitative and quantitative assessment of the aortic root including measurements for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta.
Other Names:
  • CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ascending aorta diameters changes.
Time Frame: At least 90 days after intervention.
Evaluation of ascending aorta diameters after transcatheter or surgical aortic valve replacement highlighted by both CT and echocardiographic assessment.
At least 90 days after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Giovanni A Chiariello, MD, Policlinico Agostino Gemelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2023

Primary Completion (ANTICIPATED)

January 21, 2024

Study Completion (ANTICIPATED)

January 21, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5239

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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