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Heart Valve DiseasesCORONATENCT05714293

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

A study testing CT scan with contrast medium in people with Heart Valve Diseases and Aortic Valve Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
CT scan with contrast medium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteItaly
Study dates
11 Jan 2023to 10 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
  • Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
  • CT imaging of the thorax with iodinated contrast agent carried out before surgery;
  • Signed informed consent, inclusive of release of medical information.

Who cannot join

  • Aortic valve replacement in bicuspid valve 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;
Show all 9Show fewer
  • Pregnant at time of screening;
  • Allergy or hypersensitivity to iodinated contrast agent;
  • End-stage renal disease on dialysis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site
  • Policlinico Agostino Gemelli

    Roma, 00168

Other trials in Italy

About this study

The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.

Read the detailed description

Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.

Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.

All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.

Being tested
CT scan with contrast medium
Keywords
Aortic valve replacement, Aortic valve bioprosthesis, Coronary ostia obstruction, Valve-in-valve, Transcatheter aortic valve implantation, Aortic valve stenosis, Tricuspid aortic valve, Aortic valve regurgitation, CT coronary angiogram, Transcatheter aortic valve replacement
Medical subject headings
Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Bites and Stings, Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT scan with contrast mediumRadiation

    Also called CT scan

    Multi-detector CT scan (if possible with prospective-ECG gated sequential scan) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement.

Study groups in NCT05714293
Study groupRoleWhat they receive
Surgical Aortic Valve ReplacementExperimentalPatients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.
Receives: Radiation: CT scan with contrast medium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary ostia height differences.

    Differences in coronary ostia height before and after surgical aortic valve replacement.

    Measured: At least 90 days after surgery

Secondary outcomes (1)
  1. Coronary ostia height differences between different bioprostheses.

    Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.

    Measured: At least 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start11 Jan 2023
  3. Primary completion10 Nov 2025 (estimated)
  4. Study completion10 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714293
Sponsor's protocol ID
5316
Acronym
CORONATE
Status last verified
Aug 2025
First submitted
27 Jan 2023
Last updated
15 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.

    PubMed 9060903
  • 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.

    PubMed 34453165
  • Dunning J, Gao H, Chambers J, Moat N, Murphy G, Pagano D, Ray S, Roxburgh J, Bridgewater B. Aortic valve surgery: marked increases in volume and significant decreases in mechanical valve use--an analysis of 41,227 patients over 5 years from the Society for Cardiothoracic Surgery in Great Britain and Ireland National database. J Thorac Cardiovasc Surg. 2011 Oct;142(4):776-782.e3. doi: 10.1016/j.jtcvs.2011.04.048.

    PubMed 21924147
  • Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.

    PubMed 28874031
  • Giordana F, Bruno F, Conrotto F, Saglietto A, D'Ascenzo F, Grosso Marra W, Dvir D, Webb J, D'Onofrio A, Camboni D, Grubitzsch H, Duncan A, Kaneko T, Toggweiler S, Latib A, Nerla R, Salizzoni S, La Torre M, Trompeo A, D'Amico M, Rinaldi M, De Ferrari G. Incidence, predictors and outcomes of valve-in-valve TAVI: A systematic review and meta-analysis. Int J Cardiol. 2020 Oct 1;316:64-69. doi: 10.1016/j.ijcard.2020.05.058. Epub 2020 May 26.

    PubMed 32470529
  • Bernardi FLM, Dvir D, Rodes-Cabau J, Ribeiro HB. Valve-in-Valve Challenges: How to Avoid Coronary Obstruction. Front Cardiovasc Med. 2019 Aug 23;6:120. doi: 10.3389/fcvm.2019.00120. eCollection 2019.

    PubMed 31508426
  • Coti I, Maierhofer U, Rath C, Werner P, Loewe C, Kocher A, Laufer G, Andreas M. Effect of conventional and rapid-deployment aortic valve replacement on the distance from the aortic annulus to coronary arteries. Interact Cardiovasc Thorac Surg. 2021 Jan 22;32(2):196-203. doi: 10.1093/icvts/ivaa247.

    PubMed 33236042
  • Bruno P, Cammertoni F, Rosenhek R, Mazza A, Pavone N, Iafrancesco M, Nesta M, Chiariello GA, Spalletta C, Graziano G, Sanesi V, D'Errico D, Massetti M. Improved Patient Recovery With Minimally Invasive Aortic Valve Surgery: A Propensity-Matched Study. Innovations (Phila). 2019 Oct;14(5):419-427. doi: 10.1177/1556984519868715. Epub 2019 Aug 21.

    PubMed 31431105
  • Freeman LA, Young PM, Foley TA, Williamson EE, Bruce CJ, Greason KL. CT and MRI assessment of the aortic root and ascending aorta. AJR Am J Roentgenol. 2013 Jun;200(6):W581-92. doi: 10.2214/AJR.12.9531.

    PubMed 23701088
  • Salgado RA, Leipsic JA, Shivalkar B, Ardies L, Van Herck PL, Op de Beeck BJ, Vrints C, Rodrigus I, Parizel PM, Bosmans J. Preprocedural CT evaluation of transcatheter aortic valve replacement: what the radiologist needs to know. Radiographics. 2014 Oct;34(6):1491-514. doi: 10.1148/rg.346125076.

    PubMed 25310413
  • Salemi A, Worku BM. Standard imaging techniques in transcatheter aortic valve replacement. J Thorac Dis. 2017 Apr;9(Suppl 4):S289-S298. doi: 10.21037/jtd.2017.03.114.

    PubMed 28540072

Questions about this trial

What is this clinical trial studying?

A study testing CT scan with contrast medium in people with Heart Valve Diseases and Aortic Valve Stenosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary ostia height differences. (time frame: At least 90 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05714293, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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