Comparison of Two Pericardial Bioprostheses in AVR

Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03796442

Enrollment

140

Registered

2019-01-08

Start date

2019-01-23

Completion date

2022-05-31

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Keywords

aortic valve replacement, bioprosthesis

Brief summary

The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.

Detailed description

This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.

Interventions

DEVICEAVR with AVALUS

aortic valve replacement with AVALUS bioprosthesis

DEVICEAVR with CEPME

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients who are going to undergo aortic valve replacement with bioprosthesis

Exclusion criteria

* heart failure with severe LV dysfunction (LV EF \<30%) * active infective endocarditis * with other critical cardiovascular disease (e.g. acute aortic dissection) * with other critical comorbities by which the expected life span is less than 1 year * inadequate participant by the researcher's discretion

Design outcomes

Primary

Measure	Time frame	Description
Transvalvular Mean Pressure Gradient (mPG)	at postoperative 1 year	transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Secondary

Measure	Time frame	Description
Number of Participants With Op Mortality	at postoperative 30 days or at the time of discharge	any death within 30 days after surgery or during the same hospital admission
Number of Participants With Op Morbidities	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
Effective Orifice Area (EOA)	at postoperative 1 year	effective orifice area measured by trans-thoracic echocardiography
Number of Participants With Cardiac Death	at postoperative 1 year	Any death related to cardiac events, including sudden death during follow-up
Number of Participants With Aortic Valve-related Events	at postoperative 1 year	valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation
Number of Participants With All-cause Mortality	at postoperative 1 year	patients who died from any cause

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
AVALUS Group patients who will undergo aortic valve replacement with Avalus bioprosthesis AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis	70
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	70
Total	140

Baseline characteristics

Characteristic	CEPME Group	Total	AVALUS Group
Age, Continuous	74.3 years STANDARD_DEVIATION 6.9	72.8 years STANDARD_DEVIATION 6.4	71.4 years STANDARD_DEVIATION 5.5
Atrial fibrillation	7 Participants	15 Participants	8 Participants
Body mass index	24.4 kg/m^2 STANDARD_DEVIATION 2.8	24.6 kg/m^2 STANDARD_DEVIATION 3.1	24.8 kg/m^2 STANDARD_DEVIATION 3.4
Body surface area	1.65 m^2 STANDARD_DEVIATION 0.15	1.65 m^2 STANDARD_DEVIATION 0.16	1.64 m^2 STANDARD_DEVIATION 0.18
Chronic kidney disease	18 Participants	26 Participants	8 Participants
Chronic obstructive pulmonary disease	9 Participants	13 Participants	4 Participants
Diabetes mellitus	24 Participants	48 Participants	24 Participants
Dyslipidemia	31 Participants	73 Participants	42 Participants
EuroSCORE II	2.11 units on a scale STANDARD_DEVIATION 1.67	1.99 units on a scale STANDARD_DEVIATION 1.54	1.87 units on a scale STANDARD_DEVIATION 1.41
Hypertension	47 Participants	99 Participants	52 Participants
Peripheral vascular disease	2 Participants	3 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	70 Participants	140 Participants	70 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment South Korea	70 participants	140 participants	70 participants
Reoperation	1 Participants	2 Participants	1 Participants
Sex: Female, Male Female	33 Participants	69 Participants	36 Participants
Sex: Female, Male Male	37 Participants	71 Participants	34 Participants
Stroke	7 Participants	14 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 70	6 / 70
other Total, other adverse events	0 / 70	0 / 70
serious Total, serious adverse events	5 / 70	6 / 70