NCT05804240

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): full sternotomy surgical AVR (full-SAVR), mini-sternotomy surgical AVR (mini-SAVR), and transcatheter AVR (TAVR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

March 7, 2023

Results QC Date

February 2, 2026

Last Update Submit

May 12, 2026

Conditions

Right Ventricular Dysfunction

Keywords

Right ventricular dysfunctionThree-dimensional transesophageal echocardiographySurgical aortic valve replacementMini-sternotomy aortic valve replacementTranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

  • 3D RVEF (Baseline)

    RVEF assessed using 3D TEE at baseline

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

  • %Change in 3D RVEF (From Baseline to Postop)

    (Postop 3D RVEF-baseline 3D RVEF)\*100/baseline 3D RVEF

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

Secondary Outcomes (4)

  • TAPSE (Baseline)

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

  • RV FAC (Baseline)

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

  • %Change in RV FAC (From Baseline to Postop)

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

  • %Change in TAPSE (From Baseline to Postop)

    For SAVR and mini AVR, baseline is post general anesthesia induction, and postop is after chest closure, up to the end of procedure. For TAVR, baseline is post general anesthesia induction, and postop is after valve deployment, up to the end of procedure.

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 RVEFDIAGNOSTIC_TEST

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

Mini-sternotomy aortic valve replacementSurgical aortic valve replacementTranscatheter aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

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: 25559473RESULT

  • 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: 23623594RESULT

  • 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: 29741615RESULT

  • 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: 22689711RESULT

  • 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: 27330520RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Yoshihisa Morita
Organization
Thomas Jefferson University
moritayoshihisa2016@gmail.com
2155036472

Study Officials

  • Yoshihisa Morita, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

May 13, 2026

Results First Posted

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)