Trial Outcomes & Findings for TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR (NCT NCT05804240)
NCT ID: NCT05804240
Last Updated: 2026-05-13
Results Overview
RVEF assessed using 3D TEE at baseline
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
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 posted on
2026-05-13
Participant Flow
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.
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)
Participant milestones
| Measure |
Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)
Patients who have full-sternotomy surgical aortic valve replacement
|
Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)
Patients who have mini-sternotomy surgical aortic valve replacement
|
TAVR (Transcatheter Aortic Valve Replacement)
Patients who have transcatheter aortic valve replacement
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
22
|
|
Overall Study
COMPLETED
|
23
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Baseline characteristics by cohort
| Measure |
Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)
n=23 Participants
Patients who have full-sternotomy surgical aortic valve replacement
|
Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)
n=22 Participants
Patients who have mini-sternotomy surgical aortic valve replacement
|
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.43 years old
STANDARD_DEVIATION 12.95 • n=1512 Participants
|
61.31 years old
STANDARD_DEVIATION 12.72 • n=504 Participants
|
75.54 years old
STANDARD_DEVIATION 6.24 • n=2016 Participants
|
67.57 years old
STANDARD_DEVIATION 12.63 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=1512 Participants
|
15 Participants
n=504 Participants
|
13 Participants
n=2016 Participants
|
45 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=1512 Participants
|
13 Participants
n=504 Participants
|
17 Participants
n=2016 Participants
|
46 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
|
Number of aortic stenosis valve disease patients
aortic stenosis
|
22 Participants
n=1512 Participants
|
17 Participants
n=504 Participants
|
21 Participants
n=2016 Participants
|
60 Participants
n=99 Participants
|
|
Number of aortic stenosis valve disease patients
aortic regurgitation
|
4 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
3D RVEF (Baseline)
|
49.11 percentage
Standard Deviation 9.14
|
44.71 percentage
Standard Deviation 7.71
|
48.74 percentage
Standard Deviation 8.55
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
%Change in 3D RVEF (From Baseline to Postop)
|
4.51 percentage of change
Standard Deviation 10.89
|
-8.36 percentage of change
Standard Deviation 18.24
|
-13.67 percentage of change
Standard Deviation 19.81
|
SECONDARY outcome
Timeframe: 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.TAPSE assessed using TEE at baseline
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
TAPSE (Baseline)
|
15.45 mm
Standard Deviation 3.99
|
14.09 mm
Standard Deviation 4.88
|
15.77 mm
Standard Deviation 4.55
|
SECONDARY outcome
Timeframe: 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 assessed using TEE at baseline
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
RV FAC (Baseline)
|
44.3 percentage
Standard Deviation 10.04
|
42.34 percentage
Standard Deviation 7.13
|
48.37 percentage
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: 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 RV FAC-baseline 3D RV FAC)\*100/baseline RV FAC
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
%Change in RV FAC (From Baseline to Postop)
|
4.35 percentage of change
Standard Deviation 12.33
|
-9.49 percentage of change
Standard Deviation 20.92
|
-8.28 percentage of change
Standard Deviation 23.88
|
SECONDARY outcome
Timeframe: 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 TAPSE-baseline TAPSE)\*100/baseline TAPSE
Outcome measures
| Measure |
TAVR (Transcatheter Aortic Valve Replacement)
n=22 Participants
Patients who have transcatheter aortic valve replacement
|
Surgical Aortic Valve Replacement
n=23 Participants
Patients who have surgical aortic valve replacement
|
Mini-sternotomy Aortic Valve Replacement
n=22 Participants
Patients who have mini-sternotomy aortic valve replacement
|
|---|---|---|---|
|
%Change in TAPSE (From Baseline to Postop)
|
10.46 percentage of change
Standard Deviation 24.17
|
-32.48 percentage of change
Standard Deviation 31.81
|
-22.14 percentage of change
Standard Deviation 32.48
|
Adverse Events
Full-SAVR (Full-sternotomy Surgical Aortic Valve Replacement)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mini-SAVR (Mini-sternotomy Surgical Aortic Valve Replacement)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAVR (Transcatheter Aortic Valve Replacement)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place