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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05708118
Other study ID # 5239
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 20, 2023
Est. completion date January 21, 2024

Study information

Verified date January 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Marialisa Nesta, MD
Phone +39 3495667812
Email marialisa.nesta@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (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.


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%.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 21, 2024
Est. primary completion date January 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Italy Policlinico Agostino Gemelli Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Burzotta 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. — View Citation

Burzotta 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. — View Citation

Fedak 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. — View Citation

Girdauskas 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. — View Citation

Girdauskas 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. — View Citation

Kim 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. — View Citation

Michelena 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. — View Citation

Michelena 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. — View Citation

Roberts 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. — View Citation

Smith 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. — View Citation

Tzemos 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. — View Citation

Vahanian 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. Erratum In: Eur Heart J. 2022 Feb 18;: — View Citation

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. — View Citation

Vincent 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. — View Citation

Yasuda 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Ascending aorta diameters changes. 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.
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