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

NCT05714293 | Enrolling By Invitation

• 1 other identifier: 5316
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Regurgitation, Aortic; Stenoses, Aortic; Aortic Regurgitation; Aortic Stenosis, Severe; Coronary; Obstruction; Valve Disease, Aortic

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

Outcome Measures

Primary Outcomes (1)

• Coronary ostia height differences.

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

  At least 90 days after surgery

Secondary Outcomes (1)

• Coronary ostia height differences between different bioprostheses.

  At least 90 days after surgery

Study Arms (1)

Surgical Aortic Valve Replacement

EXPERIMENTAL

Patients 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.

Radiation: CT scan with contrast medium

Interventions

CT scan with contrast medium RADIATION

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.

Also known as: CT scan

Surgical Aortic Valve Replacement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant at time of screening;
• Allergy or hypersensitivity to iodinated contrast agent;
• End-stage renal disease on dialysis.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Agostino Gemelli

Roma, 00168, Italy

Location

Related Publications (11)

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  PMID: 9060903 BACKGROUND

• 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.

  PMID: 34453165 BACKGROUND

• 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.

  PMID: 21924147 BACKGROUND

• 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.

  PMID: 28874031 BACKGROUND

• 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.

  PMID: 32470529 BACKGROUND

• 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.

  PMID: 31508426 BACKGROUND

• 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.

  PMID: 33236042 BACKGROUND

• 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.

  PMID: 31431105 BACKGROUND

• 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.

  PMID: 23701088 BACKGROUND

• 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.

  PMID: 25310413 BACKGROUND

• 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.

  PMID: 28540072 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Bites and Stings; Aortic Valve Disease

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Massimo Massetti, MD

  Policlinico Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: January 11, 2023
• Primary Completion: November 10, 2025
• Study Completion: January 10, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)