TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR

NCT05804240 | Recruiting DMC

• 1 other identifier: iRISID-2022-0802
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Right Ventricular Dysfunction

Keywords

Right ventricular dysfunction; Three-dimensional transesophageal echocardiography; Surgical aortic valve replacement; Mini-sternotomy aortic valve replacement; Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Postoperative course in days

  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

• ICU stay

  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

• Hospital stay

  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

Study Arms (3)

Surgical aortic valve replacement

Patients who have surgical aortic valve replacement

Diagnostic Test: 3D TEE RVEF

Mini-sternotomy aortic valve replacement

Patients who have mini-sternotomy aortic valve replacement

Diagnostic Test: 3D TEE RVEF

Transcatheter aortic valve replacement

Patients who have transcatheter aortic valve replacement

Diagnostic Test: 3D TEE RVEF

Interventions

3D TEE RVEF DIAGNOSTIC_TEST

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

Mini-sternotomy aortic valve replacement; Surgical aortic valve replacement; Transcatheter aortic valve replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital

You may qualify if:

• Adult patients over 18 years old
• Patients who had SAVR, mini AVR, or TAVR

You may not qualify if:

• Patients' refusal
• Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 25559473 RESULT

• 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.

  PMID: 23623594 RESULT

• 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.

  PMID: 29741615 RESULT

• 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.

  PMID: 22689711 RESULT

• 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.

  PMID: 27330520 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yoshihisa Morita, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshihisa Morita, MD

CONTACT

215-503-6472; yoshihisa.morita@jefferson.edu

Jennifer Lessin, BA,RN,CCRC

CONTACT

215-955-5804; jennifer.lessin@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 7, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)