Assessing right ventricular function using 3D echocardiography during aortic valve replacement procedures
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
Thomas Jefferson University · NCT05804240
This study is testing a new imaging method to see how well the right side of the heart works in adults having different types of aortic valve replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05804240 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate right ventricular (RV) function in patients undergoing three types of aortic valve replacement: surgical aortic valve replacement (SAVR), mini-sternotomy aortic valve replacement (mini AVR), and transcatheter aortic valve replacement (TAVR). Utilizing three-dimensional transesophageal echocardiography (TEE), the study will compare RV ejection fraction (EF) with traditional RV function indices to determine the effectiveness of this advanced imaging technique. The goal is to enhance the understanding of RV function's impact on postoperative outcomes in cardiac surgery. The study will involve adult patients over 18 years old who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old who are scheduled for SAVR, mini AVR, or TAVR.
Not a fit: Patients who refuse participation or have suboptimal echocardiography data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative outcomes for patients undergoing aortic valve replacement by providing a more accurate assessment of right ventricular function.
How similar studies have performed: Previous studies have indicated that 3D echocardiography may provide better assessments of RV function compared to traditional methods, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Yoshihisa Morita, MD — Thomas Jefferson University
- Study coordinator: Yoshihisa Morita, MD
- Email: yoshihisa.morita@jefferson.edu
- Phone: 215-503-6472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Right Ventricular Dysfunction, Right ventricular dysfunction, Three-dimensional transesophageal echocardiography, Surgical aortic valve replacement, Mini-sternotomy aortic valve replacement, Transcatheter aortic valve replacement