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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05804240
Collaborator
(none)
78
1
12
6.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3D TEE RVEF

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 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
78 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Utility of Three-dimensional Transesophageal Echocardiography in Right Ventricular Function Assessment in Surgical Aortic Valve Replacement, Mini-sternotomy Aortic Valve Replacement, and Transcatheter Aortic Valve Replacement
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Surgical aortic valve replacement

Patients who have surgical aortic valve replacement

Diagnostic Test: 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

Diagnostic Test: 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

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

Outcome Measures

Primary Outcome Measures

  1. RV function assessment indices with TEE (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.]

    3D RV EF

  2. RV function assessment indices with TEE (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 size

  3. RV function assessment indices with TEE (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.]

    RIMP

  4. RV function assessment indices with TEE (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 FAC

  5. RV function assessment indices with TEE (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.]

    S'

  6. RV function assessment indices with TEE (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.]

    TAPSE

  7. RV function assessment indices with TEE (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.]

    STE

Secondary Outcome Measures

  1. 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]

    Intubation time (if extubated in OR, it will be 0 day)

  2. 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]

    Postoperative course in days

  3. 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]

    Postoperative course in days.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

  • Principal Investigator: Yoshihisa Morita, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT05804240
Other Study ID Numbers:
  • iRISID-2022-0802
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Jefferson University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023