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CompletedNCT05804240Updated May 13, 2026Results posted

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

An observational study in Right Ventricular Dysfunction, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Thomas Jefferson University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
67
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed 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 fractional area change (FAC),, tricuspid annular plane systolic excursion (TAPSE) in full-SAVR, mini-SAVR, and TAVR.

02

Conditions studied

  • Right Ventricular Dysfunction

Keywords

  • Right ventricular dysfunction
  • Three-dimensional transesophageal echocardiography
  • Surgical aortic valve replacement
  • Mini-sternotomy aortic valve replacement
  • Transcatheter aortic valve replacement
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 67 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 393 studies on the registry; 70 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.

Browse Thomas Jefferson University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Patients' refusal
  • Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
67 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic test3D TEE RVEF

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

06

What researchers measure

Primary outcomes

  1. 3D RVEF (Baseline)

    RVEF assessed using 3D TEE at baseline

    Time frame: 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.

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

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

    Time frame: 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

  1. TAPSE (Baseline)

    TAPSE assessed using TEE at baseline

    Time frame: 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.

  2. RV FAC (Baseline)

    RV FAC assessed using TEE at baseline

    Time frame: 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.

  3. %Change in RV FAC (From Baseline to Postop)

    (Postop RV FAC-baseline 3D RV FAC)\*100/baseline RV FAC

    Time frame: 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.

  4. %Change in TAPSE (From Baseline to Postop)

    (Postop TAPSE-baseline TAPSE)\*100/baseline TAPSE

    Time frame: 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.

07

Results

Posted May 13, 2026

Participant flow

The included patients were aged \> 18 years and underwent TAVR, mini-SAVR, and full-SAVR, or TAVR requiring intraoperative transesophageal echocardiography (TEE) between April 2023 and April 2025 at Thomas Jefferson University Hospital.

Participant flow — Overall Study
MilestoneFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
Started232222
Completed232222
Not completed000

Outcome measures

Primary3D RVEF (Baseline)

RVEF assessed using 3D TEE at baseline

Time frame:
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.
Reported as:
Mean · percentage
3D RVEF (Baseline)
percentageFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
3D RVEF (Baseline)44.71 ± 7.7148.74 ± 8.5549.11 ± 9.14
Statistical analysis
  • Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement) vs Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement) vs TAVR (Transcatheter Aortic Valve Replacement) · ANOVA · p = 0.0167 (Bonferroni-adjusted p-value) · Mean difference (final values): 0.003
Primary%Change in 3D RVEF (From Baseline to Postop)

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

Time frame:
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.
Reported as:
Mean · percentage of change
%Change in 3D RVEF (From Baseline to Postop)
percentage of changeFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
%Change in 3D RVEF (From Baseline to Postop)-8.36 ± 18.24-13.67 ± 19.814.51 ± 10.89
SecondaryTAPSE (Baseline)

TAPSE assessed using TEE at baseline

Time frame:
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.
Reported as:
Mean · mm
TAPSE (Baseline)
mmSurgical Aortic Valve ReplacementMini-sternotomy Aortic Valve ReplacementTranscatheter Aortic Valve Replacement
TAPSE (Baseline)14.09 ± 4.8815.77 ± 4.5515.45 ± 3.99
Statistical analysis
  • Surgical Aortic Valve Replacement vs Mini-sternotomy Aortic Valve Replacement vs Transcatheter Aortic Valve Replacement · ANOVA · p = 0.0167 (Bonferroni-adjusted p-value) · Median difference (final values): 0.001
SecondaryRV FAC (Baseline)

RV FAC assessed using TEE at baseline

Time frame:
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.
Reported as:
Mean · percentage
RV FAC (Baseline)
percentageFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
RV FAC (Baseline)42.34 ± 7.1348.37 ± 7.9944.3 ± 10.04
Statistical analysis
  • Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement) vs Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement) vs TAVR (Transcatheter Aortic Valve Replacement) · ANOVA · p = 0.0167 (Bonferroni-adjusted p-value) · Mean difference (final values): 0.001
Secondary%Change in RV FAC (From Baseline to Postop)

(Postop RV FAC-baseline 3D RV FAC)\*100/baseline RV FAC

Time frame:
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.
Reported as:
Mean · percentage of change
%Change in RV FAC (From Baseline to Postop)
percentage of changeFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
%Change in RV FAC (From Baseline to Postop)-9.49 ± 20.92-8.28 ± 23.884.35 ± 12.33
Secondary%Change in TAPSE (From Baseline to Postop)

(Postop TAPSE-baseline TAPSE)\*100/baseline TAPSE

Time frame:
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.
Reported as:
Mean · percentage of change
%Change in TAPSE (From Baseline to Postop)
percentage of changeFull-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)
%Change in TAPSE (From Baseline to Postop)-32.48 ± 31.81-22.14 ± 32.4810.46 ± 24.17

Adverse events

Collected over From enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)0/23 (0%)0/23 (0%)0/23 (0%)
Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)0/22 (0%)0/22 (0%)0/22 (0%)
TAVR (Transcatheter Aortic Valve Replacement)0/22 (0%)0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years old)Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)Total
Mean65.43 ± 12.9561.31 ± 12.7275.54 ± 6.2467.57 ± 12.63
Sex: Female, Male
Sex: Female, Male(Participants)Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)Total
Female67922
Male17151345
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)Total
American Indian or Alaska Native0000
Asian2125
Native Hawaiian or Other Pacific Islander0000
Black or African American58316
White16131746
More than one race0000
Unknown or Not Reported0000
Number of aortic stenosis valve disease patients
Number of aortic stenosis valve disease patients(Participants)Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)TAVR (Transcatheter Aortic Valve Replacement)Total
aortic stenosis22172160
aortic regurgitation46515
08

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
09

References and documents

Publications

  • 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. PubMed 25559473 ↗
  • 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. PubMed 23623594 ↗
  • 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. PubMed 29741615 ↗
  • 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. PubMed 22689711 ↗
  • 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. PubMed 27330520 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05804240
Lead sponsor
Thomas Jefferson University
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Apr 1, 2023
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Results posted
May 13, 2026
Last update
May 13, 2026

Study contacts

Yoshihisa Morita, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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