Bicuspid Aortic ValveARDITAVNCT05708118
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
An observational study of Bicuspid Aortic Valve and Aortic Valve Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm
- What is being tested?
- Echocardiographic assessment. and Computed-tomography assessment
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2023to 21 Jan 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Agostino Gemelli
Roma, 00168
Marialisa Nesta, MD, +39 3495667812, marialisa.nesta@policlinicogemelli.it
Giovanni A Chiariello, MD
About this study
Official title: 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.
Read the 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%.
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases, Valvular Heart Disease, Valvular Aortic Stenosis
- Being tested
- Echocardiographic assessment., Computed-tomography assessment
- Keywords
- Heart valves, Transcatheter aortic valve implantation, Surgical aortic valve replacement, Ascending aorta aneurysm, Bicuspid aortic valve, Bicuspid aortopathy, Transfemoral TAVR
- Medical subject headings
- Bicuspid Aortic Valve Disease, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases, Heart Valve Diseases, Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic assessment.Diagnostic test
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.
Computed-tomography assessmentDiagnostic test
Also called CT scan
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Aortic Valve Replacement (SAVR) | Patients who undergo surgical aortic valve replacement through median longitudinal sternotomy. Receives: Diagnostic Test: Echocardiographic assessment.; Diagnostic Test: Computed-tomography assessment | |
| Transcatheter Aortic Valve Replacement (TAVR) | Patients who undergo transcatheter aortic valve replacement through a transfemoral access. Receives: Diagnostic Test: Echocardiographic assessment.; Diagnostic Test: Computed-tomography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascending aorta diameters changes.
Evaluation of ascending aorta diameters after transcatheter or surgical aortic valve replacement highlighted by both CT and echocardiographic assessment.
Measured: At least 90 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start20 Jan 2023
- Primary completion21 Jan 2024 (estimated)
- Study completion21 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni A Chiariello, MD, Principal investigator, Policlinico Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708118
- Sponsor's protocol ID
- 5239
- Acronym
- ARDITAV
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verma S, Siu SC. Aortic dilatation in patients with bicuspid aortic valve. N Engl J Med. 2014 May 15;370(20):1920-9. doi: 10.1056/NEJMra1207059. No abstract available.
PubMed 24827036Michelena HI, Desjardins VA, Avierinos JF, Russo A, Nkomo VT, Sundt TM, Pellikka PA, Tajik AJ, Enriquez-Sarano M. Natural history of asymptomatic patients with normally functioning or minimally dysfunctional bicuspid aortic valve in the community. Circulation. 2008 May 27;117(21):2776-84. doi: 10.1161/CIRCULATIONAHA.107.740878.
PubMed 18506017Tzemos N, Therrien J, Yip J, Thanassoulis G, Tremblay S, Jamorski MT, Webb GD, Siu SC. Outcomes in adults with bicuspid aortic valves. JAMA. 2008 Sep 17;300(11):1317-25. doi: 10.1001/jama.300.11.1317.
PubMed 18799444Kim YG, Sun BJ, Park GM, Han S, Kim DH, Song JM, Kang DH, Song JK. Aortopathy and bicuspid aortic valve: haemodynamic burden is main contributor to aortic dilatation. Heart. 2012 Dec;98(24):1822-7. doi: 10.1136/heartjnl-2012-302828.
PubMed 23204534Fedak PW, Verma S, David TE, Leask RL, Weisel RD, Butany J. Clinical and pathophysiological implications of a bicuspid aortic valve. Circulation. 2002 Aug 20;106(8):900-4. doi: 10.1161/01.cir.0000027905.26586.e8. No abstract available.
PubMed 12186790Girdauskas E, Borger MA, Secknus MA, Girdauskas G, Kuntze T. Is aortopathy in bicuspid aortic valve disease a congenital defect or a result of abnormal hemodynamics? A critical reappraisal of a one-sided argument. Eur J Cardiothorac Surg. 2011 Jun;39(6):809-14. doi: 10.1016/j.ejcts.2011.01.001. Epub 2011 Feb 20.
PubMed 21342769Michelena HI, Khanna AD, Mahoney D, Margaryan E, Topilsky Y, Suri RM, Eidem B, Edwards WD, Sundt TM 3rd, Enriquez-Sarano M. Incidence of aortic complications in patients with bicuspid aortic valves. JAMA. 2011 Sep 14;306(10):1104-12. doi: 10.1001/jama.2011.1286.
PubMed 21917581Roberts WC, Janning KG, Ko JM, Filardo G, Matter GJ. Frequency of congenitally bicuspid aortic valves in patients >/=80 years of age undergoing aortic valve replacement for aortic stenosis (with or without aortic regurgitation) and implications for transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1632-6. doi: 10.1016/j.amjcard.2012.01.390. Epub 2012 Mar 27.
PubMed 22459301Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
PubMed 21639811Vincent F, Ternacle J, Denimal T, Shen M, Redfors B, Delhaye C, Simonato M, Debry N, Verdier B, Shahim B, Pamart T, Spillemaeker H, Schurtz G, Pontana F, Thourani VH, Pibarot P, Van Belle E. Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis. Circulation. 2021 Mar 9;143(10):1043-1061. doi: 10.1161/CIRCULATIONAHA.120.048048. Epub 2021 Mar 8.
PubMed 33683945Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165Yasuda H, Nakatani S, Stugaard M, Tsujita-Kuroda Y, Bando K, Kobayashi J, Yamagishi M, Kitakaze M, Kitamura S, Miyatake K. Failure to prevent progressive dilation of ascending aorta by aortic valve replacement in patients with bicuspid aortic valve: comparison with tricuspid aortic valve. Circulation. 2003 Sep 9;108 Suppl 1:II291-4. doi: 10.1161/01.cir.0000087449.03964.fb.
PubMed 12970248Girdauskas E, Rouman M, Disha K, Espinoza A, Misfeld M, Borger MA, Kuntze T. Aortic Dissection After Previous Aortic Valve Replacement for Bicuspid Aortic Valve Disease. J Am Coll Cardiol. 2015 Sep 22;66(12):1409-11. doi: 10.1016/j.jacc.2015.07.022. No abstract available.
PubMed 26383730Burzotta F, Aurigemma C, Romagnoli E, Shoeib O, Russo G, Zambrano A, Verdirosi D, Leone AM, Bruno P, Trani C. A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020 Aug;96(2):459-470. doi: 10.1002/ccd.28697. Epub 2020 Jan 11.
PubMed 31925991Burzotta F, Shoeib O, Aurigemma C, Trani C. Angio-Guidewire-Ultrasound (AGU) Guidance for Femoral Access in Procedures Requiring Large Sheaths. J Invasive Cardiol. 2019 Feb;31(2):E37-E39. doi: 10.25270/jic/18.00173.
PubMed 30700629