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

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Thomas Jefferson University

Status

Enrolling

Conditions

Right Ventricular Dysfunction

Treatments

Diagnostic Test: 3D TEE RVEF

Study type

Observational

Funder types

Other

Identifiers

NCT05804240
iRISID-2022-0802

Details and patient eligibility

About

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).

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

78 participants in 3 patient groups

Surgical aortic valve replacement
Description:
Patients who have surgical aortic valve replacement
Treatment:
Diagnostic Test: 3D TEE RVEF
Mini-sternotomy aortic valve replacement
Description:
Patients who have mini-sternotomy aortic valve replacement
Treatment:
Diagnostic Test: 3D TEE RVEF
Transcatheter aortic valve replacement
Description:
Patients who have transcatheter aortic valve replacement
Treatment:
Diagnostic Test: 3D TEE RVEF

Trial contacts and locations

1

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Central trial contact

Yoshihisa Morita, MD; Jennifer Lessin, BA,RN,CCRC

Data sourced from clinicaltrials.gov

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