Aortic Valve Stenosis Clinical Trial
— CORONATEOfficial title:
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Verified date | February 2024 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 90 |
Est. completion date | January 10, 2025 |
Est. primary completion date | November 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Agostino Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Radiographics. 2015 Jan-Feb;35(1):299. — View Citation
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. — 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
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary ostia height differences. | Differences in coronary ostia height before and after surgical aortic valve replacement. | At least 90 days after surgery | |
Secondary | Coronary ostia height differences between different bioprostheses. | Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used. | At least 90 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03186339 -
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
|
||
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Terminated |
NCT02854319 -
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
|
N/A | |
Recruiting |
NCT05601453 -
The ReTAVI Prospective Observational Registry
|
||
Withdrawn |
NCT05481814 -
CPX in Paradoxical Low Flow Aortic Stenosis
|
||
Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
Completed |
NCT01700439 -
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
|
N/A | |
Recruiting |
NCT04429035 -
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
|
N/A | |
Completed |
NCT04103931 -
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
|
N/A | |
Completed |
NCT03950440 -
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
|
||
Active, not recruiting |
NCT02661451 -
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
|
N/A | |
Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
Completed |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
Not yet recruiting |
NCT02541877 -
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
|
Phase 3 | |
Not yet recruiting |
NCT02536703 -
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
|
Phase 3 | |
Not yet recruiting |
NCT02221921 -
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
|
N/A | |
Completed |
NCT02249000 -
BIOVALVE - I / II Clincial Investigation
|
N/A | |
Active, not recruiting |
NCT02080299 -
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
|
Phase 2 | |
Terminated |
NCT01939678 -
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
|