Trial Outcomes & Findings for Comparison of Two Pericardial Bioprostheses in AVR (NCT NCT03796442)
NCT ID: NCT03796442
Last Updated: 2023-02-08
Results Overview
transvalvular mean pressure gradient measured by trans-thoracic echocardiography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
at postoperative 1 year
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
AVALUS Group
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
66
|
63
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Pericardial Bioprostheses in AVR
Baseline characteristics by cohort
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
74.3 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
72.8 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
70 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
70 participants
n=99 Participants
|
70 participants
n=107 Participants
|
140 participants
n=206 Participants
|
|
Body mass index
|
24.8 kg/m^2
STANDARD_DEVIATION 3.4 • n=99 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 2.8 • n=107 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Body surface area
|
1.64 m^2
STANDARD_DEVIATION 0.18 • n=99 Participants
|
1.65 m^2
STANDARD_DEVIATION 0.15 • n=107 Participants
|
1.65 m^2
STANDARD_DEVIATION 0.16 • n=206 Participants
|
|
Diabetes mellitus
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Hypertension
|
52 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Dyslipidemia
|
42 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Chronic obstructive pulmonary disease
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Stroke
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Chronic kidney disease
|
8 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Peripheral vascular disease
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Atrial fibrillation
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Reoperation
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
EuroSCORE II
|
1.87 units on a scale
STANDARD_DEVIATION 1.41 • n=99 Participants
|
2.11 units on a scale
STANDARD_DEVIATION 1.67 • n=107 Participants
|
1.99 units on a scale
STANDARD_DEVIATION 1.54 • n=206 Participants
|
PRIMARY outcome
Timeframe: at postoperative 1 yeartransvalvular mean pressure gradient measured by trans-thoracic echocardiography
Outcome measures
| Measure |
AVALUS Group
n=66 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=63 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Transvalvular Mean Pressure Gradient (mPG)
|
14.1 mmHg
Standard Deviation 4.3
|
13.9 mmHg
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: at postoperative 1 yeareffective orifice area measured by trans-thoracic echocardiography
Outcome measures
| Measure |
AVALUS Group
n=66 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=63 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Effective Orifice Area (EOA)
|
1.48 cm2
Standard Deviation 0.39
|
1.53 cm2
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: at postoperative 30 days or at the time of dischargeany death within 30 days after surgery or during the same hospital admission
Outcome measures
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Number of Participants With Op Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at postoperative 1 yearlow cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection
Outcome measures
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Number of Participants With Op Morbidities
Complete atrioventricular block
|
2 Participants
|
0 Participants
|
|
Number of Participants With Op Morbidities
Bleeding reoperation
|
1 Participants
|
1 Participants
|
|
Number of Participants With Op Morbidities
No complication
|
32 Participants
|
33 Participants
|
|
Number of Participants With Op Morbidities
Respiratory complication
|
6 Participants
|
7 Participants
|
|
Number of Participants With Op Morbidities
Postoperative atrial fibrillation
|
21 Participants
|
24 Participants
|
|
Number of Participants With Op Morbidities
Acute kidney injury
|
4 Participants
|
2 Participants
|
|
Number of Participants With Op Morbidities
Stroke
|
2 Participants
|
2 Participants
|
|
Number of Participants With Op Morbidities
Low cardiac output
|
2 Participants
|
1 Participants
|
|
Number of Participants With Op Morbidities
Mediastinitis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Op Morbidities
Infective endocarditis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at postoperative 1 yearpatients who died from any cause
Outcome measures
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Number of Participants With All-cause Mortality
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: at postoperative 1 yearAny death related to cardiac events, including sudden death during follow-up
Outcome measures
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Number of Participants With Cardiac Death
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at postoperative 1 yearvalve-related mortality, thromboembolism, bleeding, endocarditis, reoperation
Outcome measures
| Measure |
AVALUS Group
n=70 Participants
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 Participants
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Number of Participants With Aortic Valve-related Events
|
5 Participants
|
6 Participants
|
Adverse Events
AVALUS Group
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
CEPME Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
AVALUS Group
n=70 participants at risk
patients who will undergo aortic valve replacement with Avalus bioprosthesis
AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis
|
CEPME Group
n=70 participants at risk
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
|
|---|---|---|
|
Cardiac disorders
cardiac deaths
|
1.4%
1/70 • 1 year
|
2.9%
2/70 • 1 year
|
|
Cardiac disorders
nonstructural valve dysfunction
|
1.4%
1/70 • 1 year
|
4.3%
3/70 • 1 year
|
|
Cardiac disorders
thromboembolism
|
0.00%
0/70 • 1 year
|
2.9%
2/70 • 1 year
|
|
Cardiac disorders
bleeding event
|
1.4%
1/70 • 1 year
|
0.00%
0/70 • 1 year
|
|
Cardiac disorders
prosthetic valve endocarditis
|
2.9%
2/70 • 1 year
|
1.4%
1/70 • 1 year
|
|
Cardiac disorders
permanent pacemaker implantation
|
2.9%
2/70 • 1 year
|
0.00%
0/70 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Prof. Ho Young Hwang
Seoul National University Hospital
Phone: 00-82-2-2072-3020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place