Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
78 participants
OBSERVATIONAL
2023-04-01
2025-06-30
Brief Summary
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Detailed Description
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In this study, the investigators plan to evaluate intraoperative RV function assessment by 3D transesophageal echocardiography (TEE). The investigators will compare 3D RV EF with other traditional RV function indices (RV size, Right Ventricular Index of Myocardial Performance (RIMP), RV fractional area change (FAC), peak systolic velocity of the lateral tricuspid annulus (S'), tricuspid annular plane systolic excursion (TAPSE), speckle tracking echocardiography (STE) in SAVR, mini-sternotomy AVR (mini AVR), and TAVR.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical aortic valve replacement
Patients who have surgical aortic valve replacement
3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Mini-sternotomy aortic valve replacement
Patients who have mini-sternotomy aortic valve replacement
3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Transcatheter aortic valve replacement
Patients who have transcatheter aortic valve replacement
3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Interventions
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3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
Eligibility Criteria
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Inclusion Criteria
* Patients who had SAVR, mini AVR, or TAVR
Exclusion Criteria
* Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
18 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Yoshihisa Morita, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
Ternacle J, Berry M, Cognet T, Kloeckner M, Damy T, Monin JL, Couetil JP, Dubois-Rande JL, Gueret P, Lim P. Prognostic value of right ventricular two-dimensional global strain in patients referred for cardiac surgery. J Am Soc Echocardiogr. 2013 Jul;26(7):721-6. doi: 10.1016/j.echo.2013.03.021. Epub 2013 Apr 25.
Cremer PC, Zhang Y, Alu M, Rodriguez LL, Lindman BR, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Leon MB, Jaber WA. The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA. Eur Heart J. 2018 Jul 21;39(28):2659-2667. doi: 10.1093/eurheartj/ehy251.
Kempny A, Diller GP, Kaleschke G, Orwat S, Funke A, Schmidt R, Kerckhoff G, Ghezelbash F, Rukosujew A, Reinecke H, Scheld HH, Baumgartner H. Impact of transcatheter aortic valve implantation or surgical aortic valve replacement on right ventricular function. Heart. 2012 Sep;98(17):1299-304. doi: 10.1136/heartjnl-2011-301203. Epub 2012 Jun 11.
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
Other Identifiers
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iRISID-2022-0802
Identifier Type: -
Identifier Source: org_study_id
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