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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804240
Other study ID # iRISID-2022-0802
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date April 30, 2024

Study information

Verified date August 2023
Source Thomas Jefferson University
Contact Yoshihisa Morita, MD
Phone 215-503-6472
Email yoshihisa.morita@jefferson.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve replacement (AVR): surgical AVR (SAVR), mini-sternotomy AVR (mini AVR), and transcatheter AVR (TAVR).


Description:

Objective: Right ventricular (RV) function is known to be a critical factor to determine postoperative outcome in cardiac surgery, and echocardiography plays an important role in RV function assessment. In the previous studies, RV function was reported to be more reduced in surgical aortic valve replacement (SAVR) than transcatheter aortic valve replacement (TAVR), but its assessment was performed by 2-dimensional echocardiography. On the other hand, three-dimensional (3D) echocardiography has been the gold standard to assess RV systolic function (EF: ejection fraction), and its intraoperative use is getting more useful in cardiac surgery given recent technological advance in echocardiography machines. However, realty is that RV function assessment is based on subjective information or traditional RV function indices, mostly due to unfamiliarity of 3D technique. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients over 18 years old - Patients who had SAVR, mini AVR, or TAVR Exclusion criteria: - Patients' refusal - Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE

Study Design


Intervention

Diagnostic Test:
3D TEE RVEF
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view

Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 t — View Citation

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 functi — View Citation

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. Erratum In: J Chiropr Med. 2017 Dec;16(4):346. — View Citation

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 quantif — View Citation

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) — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary RV function assessment indices with TEE (3D RV EF) 3D RV EF For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (RV size) RV size For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (RIMP) RIMP For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (RV FAC) RV FAC For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (S') S' For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (TAPSE) TAPSE For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Primary RV function assessment indices with TEE (STE) STE For SAVR and mini AVR, post general anesthesia induction, post cardiopulmonary bypass, and after chest closure, up to the end of procedure. For TAVR, post general anesthesia induction and after valve deployment, up to the end of procedure.
Secondary Postoperative course in days Intubation time (if extubated in OR, it will be 0 day) Postoperative course till patient is discharged from hospital. From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary ICU stay Postoperative course in days From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary Hospital stay Postoperative course in days. From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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