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Lung Ultrasound in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Replacement: a Prospective Study
Sponsor study identifier
observational
150
1 country
1
Study Start
July 20, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2021
Actual (reported)August 10, 2021
Actual (reported)August 27, 2021
Actual (reported)April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
change of LUS-evaluated pulmonary congestion in patients with severe aortic stenosis undergoing TAVR
pre-intervention (baseline) and after the intervention within 72 hours
to evaluate the possible prognostic role of LUS-evaluated pulmonary congestion at 12 months follow-up.
One year after hospital discharge.
Severe aortic stenosis patients undergoing TAVR will be stratified according to LUS evaluated pulmonary congestion before and after TAVR
Transfemoral transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly (aortic valve stenosis) through an incision in the groin. All FDA approved transcatheter aortic prosthesys are allowed.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients undergoing TAVR for severe aortic stenosis could participate in the study and therefore, be evaluated according to the selection criteria defined in the protocol.
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Rome, 00168, Italy
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
First Submitted
August 10, 2021
First Posted
August 27, 2021
Study Start
July 20, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)Contact the study team to confirm eligibility.
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
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Lindman BR, Stewart WJ, Pibarot P, Hahn RT, Otto CM, Xu K, Devereux RB, Weissman NJ, Enriquez-Sarano M, Szeto WY, Makkar R, Miller DC, Lerakis S, Kapadia S, Bowers B, Greason KL, McAndrew TC, Lei Y, Leon MB, Douglas PS. Early regression of severe left ventricular hypertrophy after transcatheter aortic valve replacement is associated with decreased hospitalizations. JACC Cardiovasc Interv. 2014 Jun;7(6):662-73. doi: 10.1016/j.jcin.2014.02.011.
Genereux P, Pibarot P, Redfors B, Mack MJ, Makkar RR, Jaber WA, Svensson LG, Kapadia S, Tuzcu EM, Thourani VH, Babaliaros V, Herrmann HC, Szeto WY, Cohen DJ, Lindman BR, McAndrew T, Alu MC, Douglas PS, Hahn RT, Kodali SK, Smith CR, Miller DC, Webb JG, Leon MB. Staging classification of aortic stenosis based on the extent of cardiac damage. Eur Heart J. 2017 Dec 1;38(45):3351-3358. doi: 10.1093/eurheartj/ehx381.
Vemulapalli S, Dai D, Hammill BG, Baron SJ, Cohen DJ, Mack MJ, Holmes DR Jr. Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry. J Am Coll Cardiol. 2019 Mar 19;73(10):1135-1146. doi: 10.1016/j.jacc.2018.12.049.
Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, Dickstein K, Drazner MH, Fonarow GC, Jaarsma T, Jondeau G, Sendon JL, Mebazaa A, Metra M, Nieminen M, Pang PS, Seferovic P, Stevenson LW, van Veldhuisen DJ, Zannad F, Anker SD, Rhodes A, McMurray JJ, Filippatos G; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the acute heart failure committee of the heart failure association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010 May;12(5):423-33. doi: 10.1093/eurjhf/hfq045. Epub 2010 Mar 30.
Zile MR, Bennett TD, St John Sutton M, Cho YK, Adamson PB, Aaron MF, Aranda JM Jr, Abraham WT, Smart FW, Stevenson LW, Kueffer FJ, Bourge RC. Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures. Circulation. 2008 Sep 30;118(14):1433-41. doi: 10.1161/CIRCULATIONAHA.108.783910. Epub 2008 Sep 15.
Rivas-Lasarte M, Maestro A, Fernandez-Martinez J, Lopez-Lopez L, Sole-Gonzalez E, Vives-Borras M, Montero S, Mesado N, Pirla MJ, Mirabet S, Fluvia P, Brossa V, Sionis A, Roig E, Cinca J, Alvarez-Garcia J. Prevalence and prognostic impact of subclinical pulmonary congestion at discharge in patients with acute heart failure. ESC Heart Fail. 2020 Oct;7(5):2621-2628. doi: 10.1002/ehf2.12842. Epub 2020 Jul 7.
Platz E, Campbell RT, Claggett B, Lewis EF, Groarke JD, Docherty KF, Lee MMY, Merz AA, Silverman M, Swamy V, Lindner M, Rivero J, Solomon SD, McMurray JJV. Lung Ultrasound in Acute Heart Failure: Prevalence of Pulmonary Congestion and Short- and Long-Term Outcomes. JACC Heart Fail. 2019 Oct;7(10):849-858. doi: 10.1016/j.jchf.2019.07.008.
Picano E, Scali MC, Ciampi Q, Lichtenstein D. Lung Ultrasound for the Cardiologist. JACC Cardiovasc Imaging. 2018 Nov;11(11):1692-1705. doi: 10.1016/j.jcmg.2018.06.023.
Araiza-Garaygordobil D, Gopar-Nieto R, Martinez-Amezcua P, Cabello-Lopez A, Alanis-Estrada G, Luna-Herbert A, Gonzalez-Pacheco H, Paredes-Paucar CP, Sierra-Lara MD, Briseno-De la Cruz JL, Rodriguez-Zanella H, Martinez-Rios MA, Arias-Mendoza A. A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study). Am Heart J. 2020 Sep;227:31-39. doi: 10.1016/j.ahj.2020.06.003. Epub 2020 Jun 15.
Lillo R, Cangemi S, Graziani F, Locorotondo G, Pedicino D, Aurigemma C, Romagnoli E, Malara S, Meucci MC, Iannaccone G, Bianchini F, Nesta M, Bruno P, Lombardo A, Trani C, Burzotta F. Pulmonary congestion assessed by lung ultrasound in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: Prevalence and prognostic implications. Eur J Heart Fail. 2024 Oct;26(10):2107-2117. doi: 10.1002/ejhf.3365. Epub 2024 Jul 16.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 27, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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