Right Ventricular DysfunctionNCT05804240
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
An observational study of Right Ventricular Dysfunction, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- 3D TEE RVEF
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital
Who may be able to join
- Adult patients over 18 years old
- Patients who had SAVR, mini AVR, or TAVR
Who cannot join
- Patients' refusal
- Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
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.
- Conditions
- Right Ventricular Dysfunction
- Being tested
- 3D TEE RVEF
- Keywords
- Right ventricular dysfunction, Three-dimensional transesophageal echocardiography, Surgical aortic valve replacement, Mini-sternotomy aortic valve replacement, Transcatheter aortic valve replacement
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D TEE RVEFDiagnostic test
With TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view
| Study group | Role | What they receive |
|---|---|---|
| Surgical aortic valve replacement | Patients who have surgical aortic valve replacement Receives: Diagnostic Test: 3D TEE RVEF | |
| Mini-sternotomy aortic valve replacement | Patients who have mini-sternotomy aortic valve replacement Receives: Diagnostic Test: 3D TEE RVEF | |
| Transcatheter aortic valve replacement | Patients who have transcatheter aortic valve replacement Receives: Diagnostic Test: 3D TEE RVEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D RVEF (Baseline)
RVEF assessed using 3D TEE at baseline
Measured: 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
Measured: 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 (4)
TAPSE (Baseline)
TAPSE assessed using TEE at baseline
Measured: 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.
RV FAC (Baseline)
RV FAC assessed using TEE at baseline
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshihisa Morita, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804240
- Sponsor's protocol ID
- iRISID-2022-0802
- Status last verified
- May 2026
- First submitted
- 7 Mar 2023
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25559473Ternacle 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 23623594Cremer 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 29741615Kempny 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 22689711Koo 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 at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05804240
- Acronym / sponsor ID
- iRISID-2022-0802
- Conditions
- Right Ventricular Dysfunction
- Keywords
- Right ventricular dysfunction, Three-dimensional transesophageal echocardiography, Surgical aortic valve replacement, Mini-sternotomy aortic valve replacement, Transcatheter aortic valve replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical aortic valve replacement | – | Diagnostic Test: 3D TEE RVEFPatients who have surgical aortic valve replacement |
| Mini-sternotomy aortic valve replacement | – | Diagnostic Test: 3D TEE RVEFPatients who have mini-sternotomy aortic valve replacement |
| Transcatheter aortic valve replacement | – | Diagnostic Test: 3D TEE RVEFPatients who have transcatheter aortic valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who had SAVR, mini AVR, and TAVR at Thomas Jefferson University Hospital
Key inclusion criteria (2 listed)
- Adult patients over 18 years old
- Patients who had SAVR, mini AVR, or TAVR
Key exclusion criteria (2 listed)
- Patients' refusal
- Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D TEE RVEFWith TEE package software, the investigators measure and calculate 3D TEE RVEF using mid esophageal 4 chamber view | Diagnostic test | Mini-sternotomy aortic valve replacement, Surgical aortic valve replacement, Transcatheter aortic valve replacement |
Primary outcome
3D RVEF (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.
RVEF assessed using 3D TEE at baseline
%Change in 3D RVEF (From Baseline to Postop)
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.
(Postop 3D RVEF-baseline 3D RVEF)*100/baseline 3D RVEF
4 secondary outcomes
TAPSE (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.
RV FAC (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.
%Change in RV FAC (From Baseline to Postop)
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.
%Change in TAPSE (From Baseline to Postop)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25559473Lang 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.
- Results publication: PubMed 23623594Ternacle 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.
- Results publication: PubMed 29741615Cremer 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.
- Results publication: PubMed 22689711Kempny 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.
- Results publication: PubMed 27330520Koo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihisa Morita, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D RVEF (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804240, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.