Heart Diseases Clinical Trial
— ARDITAVOfficial title:
Progression of the Ascending Aorta Diameter After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve.
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Agostino Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 all — Click here to view all references
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624412 -
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
|
N/A | |
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Recruiting |
NCT04561908 -
Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
|
N/A | |
Active, not recruiting |
NCT06190743 -
Perception of Cardiovascular Risk
|
||
Completed |
NCT04562636 -
Evaluating a Messaging Campaign in the United States
|
N/A | |
Completed |
NCT04580095 -
Artificial Intelligence for Improved Echocardiography
|
N/A | |
Recruiting |
NCT03277365 -
MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
|
N/A | |
Active, not recruiting |
NCT05553106 -
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
|
||
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Enrolling by invitation |
NCT03314818 -
Natural History of Carotid Plaque as Determined by 3D Ultrasound
|
N/A | |
Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
Completed |
NCT02046902 -
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
|
||
Completed |
NCT01909349 -
Web-based Aftercare Intervention for Cardiac Patients
|
N/A | |
Completed |
NCT01944254 -
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
|
N/A | |
Recruiting |
NCT01457586 -
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
|
Phase 4 | |
Recruiting |
NCT01541163 -
Heart and Ischemic STrOke Relationship studY
|
N/A | |
Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
Terminated |
NCT00968383 -
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
|
N/A |