Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement. (ARDITAV)
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| ClinicalTrials.gov Identifier: NCT05708118 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2023
Last Update Posted : February 1, 2023
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Bicuspid Aortic Valve Aortic Valve Stenosis Aortic Aneurysm Heart Diseases Valvular Heart Disease Valvular Aortic Stenosis Ascending Aorta Aneurysm | Diagnostic Test: Echocardiographic assessment. Diagnostic Test: Computed-tomography assessment |
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 |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Progression of the Ascending Aorta Diameter After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve. |
| Actual Study Start Date : | January 20, 2023 |
| Estimated Primary Completion Date : | January 21, 2024 |
| Estimated Study Completion Date : | January 21, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Surgical Aortic Valve Replacement (SAVR)
Patients who undergo surgical aortic valve replacement through median longitudinal sternotomy.
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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 Name: CT scan |
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Transcatheter Aortic Valve Replacement (TAVR)
Patients who undergo transcatheter aortic valve replacement through a transfemoral access.
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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 Name: CT scan |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05708118
| Contact: Marialisa Nesta, MD | +39 3495667812 | marialisa.nesta@policlinicogemelli.it |
| Italy | |
| Policlinico Agostino Gemelli | Recruiting |
| Roma, Italy, 00168 | |
| Contact: Marialisa Nesta, MD +39 3495667812 marialisa.nesta@policlinicogemelli.it | |
| Principal Investigator: Giovanni A Chiariello, MD | |
| Principal Investigator: | Giovanni A Chiariello, MD | Policlinico Agostino Gemelli |
| Responsible Party: | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| ClinicalTrials.gov Identifier: | NCT05708118 |
| Other Study ID Numbers: |
5239 |
| First Posted: | February 1, 2023 Key Record Dates |
| Last Update Posted: | February 1, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart valves Transcatheter aortic valve implantation Surgical aortic valve replacement Ascending aorta aneurysm |
Bicuspid aortic valve Bicuspid aortopathy Transfemoral TAVR |
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Heart Diseases Aneurysm Aortic Aneurysm Aortic Valve Stenosis Heart Valve Diseases Bicuspid Aortic Valve Disease Constriction, Pathologic Cardiovascular Diseases |
Pathological Conditions, Anatomical Vascular Diseases Aortic Diseases Aortic Valve Disease Ventricular Outflow Obstruction Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |