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

Target enrollment

140 participants

Primary outcome timeframe

at postoperative 1 year

Results posted on

2023-02-08

Participant Flow

Participant milestones

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

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=5 Participants	74.3 years STANDARD_DEVIATION 6.9 • n=7 Participants	72.8 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	37 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	70 Participants n=5 Participants	70 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Korea	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants
Body mass index	24.8 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants	24.4 kg/m^2 STANDARD_DEVIATION 2.8 • n=7 Participants	24.6 kg/m^2 STANDARD_DEVIATION 3.1 • n=5 Participants
Body surface area	1.64 m^2 STANDARD_DEVIATION 0.18 • n=5 Participants	1.65 m^2 STANDARD_DEVIATION 0.15 • n=7 Participants	1.65 m^2 STANDARD_DEVIATION 0.16 • n=5 Participants
Diabetes mellitus	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Hypertension	52 Participants n=5 Participants	47 Participants n=7 Participants	99 Participants n=5 Participants
Dyslipidemia	42 Participants n=5 Participants	31 Participants n=7 Participants	73 Participants n=5 Participants
Chronic obstructive pulmonary disease	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Stroke	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Chronic kidney disease	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Peripheral vascular disease	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Atrial fibrillation	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Reoperation	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
EuroSCORE II	1.87 units on a scale STANDARD_DEVIATION 1.41 • n=5 Participants	2.11 units on a scale STANDARD_DEVIATION 1.67 • n=7 Participants	1.99 units on a scale STANDARD_DEVIATION 1.54 • n=5 Participants

PRIMARY outcome

Timeframe: at postoperative 1 year

transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Outcome measures

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 year

effective orifice area measured by trans-thoracic echocardiography

Outcome measures

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 discharge

any death within 30 days after surgery or during the same hospital admission

Outcome measures

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 year

low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection

Outcome measures

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 Postoperative atrial fibrillation	21 Participants	24 Participants
Number of Participants With Op Morbidities Respiratory complication	6 Participants	7 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 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 Mediastinitis	0 Participants	0 Participants
Number of Participants With Op Morbidities Infective endocarditis	0 Participants	0 Participants
Number of Participants With Op Morbidities No complication	32 Participants	33 Participants

SECONDARY outcome

Timeframe: at postoperative 1 year

patients who died from any cause

Outcome measures

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 year

Any death related to cardiac events, including sudden death during follow-up

Outcome measures

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 year

valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation

Outcome measures

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

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