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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical aortic valve replacement | Patients who have surgical aortic valve replacement |
| |
| Mini-sternotomy aortic valve replacement | Patients who have mini-sternotomy aortic valve replacement |
| |
| Transcatheter aortic valve replacement | Patients who have transcatheter aortic valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D TEE RVEF | Diagnostic Test | With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TAPSE (Baseline) | TAPSE assessed using 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. |
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Inclusion Criteria:
Exclusion criteria:
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Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihisa Morita, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25559473 | Result | 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. | |
| 23623594 |
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Twenty-three (full-SAVR), 22 (mini-SAVR) and 24 (TAVR) patients were enrolled in the study. Two patients were excluded from the TAVR group owing to poor TEE image quality. Thus, there were 22 patients each in the TAVR and mini-SAVR groups and 23 patients in the full-SAVR group (a total of 67 patients)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement) | Patients who have full-sternotomy surgical aortic valve replacement |
| FG001 | Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement) | Patients who have mini-sternotomy surgical aortic valve replacement |
| FG002 | TAVR (Transcatheter Aortic Valve Replacement) | Patients who have transcatheter aortic valve replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement) | Patients who have full-sternotomy surgical aortic valve replacement |
| BG001 | Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3D RVEF (Baseline) | RVEF assessed using 3D TEE at baseline | Posted | Mean | Standard Deviation | percentage | 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. |
|
From enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement) | Patients who have full-sternotomy surgical aortic valve replacement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoshihisa Morita | Thomas Jefferson University | 2155036472 | moritayoshihisa2016@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 1, 2022 | Nov 15, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| RV FAC (Baseline) |
RV FAC assessed using 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 RV FAC (From Baseline to Postop) | (Postop RV FAC-baseline 3D RV FAC)*100/baseline RV FAC | 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) | (Postop TAPSE-baseline TAPSE)*100/baseline TAPSE | 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. |
| Result |
| 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. |
| 29741615 | Result | 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. |
| 22689711 | Result | 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. |
| 27330520 | Result | 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. |
Patients who have mini-sternotomy surgical aortic valve replacement
| BG002 | TAVR (Transcatheter Aortic Valve Replacement) | Patients who have transcatheter aortic valve replacement |
| BG003 | Total | Total of all reporting groups |
| years old |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of aortic stenosis valve disease patients | Count of Participants | Participants |
|
| OG002 | TAVR (Transcatheter Aortic Valve Replacement) | Patients who have transcatheter aortic valve replacement |
|
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| Primary | %Change in 3D RVEF (From Baseline to Postop) | (Postop 3D RVEF-baseline 3D RVEF)*100/baseline 3D RVEF | Posted | Mean | Standard Deviation | percentage of change | 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. |
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| Secondary | TAPSE (Baseline) | TAPSE assessed using TEE at baseline | Posted | Mean | Standard Deviation | mm | 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. |
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|
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| Secondary | RV FAC (Baseline) | RV FAC assessed using TEE at baseline | Posted | Mean | Standard Deviation | percentage | 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 | %Change in RV FAC (From Baseline to Postop) | (Postop RV FAC-baseline 3D RV FAC)*100/baseline RV FAC | Posted | Mean | Standard Deviation | percentage of change | 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. |
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|
|
| Secondary | %Change in TAPSE (From Baseline to Postop) | (Postop TAPSE-baseline TAPSE)*100/baseline TAPSE | Posted | Mean | Standard Deviation | percentage of change | 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. |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement) | Patients who have mini-sternotomy surgical aortic valve replacement | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | TAVR (Transcatheter Aortic Valve Replacement) | Patients who have transcatheter aortic valve replacement | 0 | 22 | 0 | 22 | 0 | 22 |
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