A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Study Overview
Brief Summary
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
Detailed Description
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age
- •aortic stenosis / mixed aortic stenosis and aortic insufficiency
- •SAVR+CABG (1-4 distal anastomoses)
- •Log. EuroSCORE ≥6
- •NYHA Class ≥II
- •Exclusion (i.a.):
- •pure aortic insufficiency
- •pre-existing prosthetic heart valve or ring
- •congenital true bicuspid / unicuspid aortic valve
- •LVEF <20%
Exclusion Criteria
- Not provided
Arms & Interventions
EDWARDS INTUITY
EDWARDS INTUITY Valve System, Model 8300A
Intervention: EDWARDS INTUITY (Device)
Stented aortic bioprostheses
Stented aortic bioprostheses
Intervention: Stented aortic bioprostheses (Device)
Outcomes
Primary Outcomes
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Time Frame: At time of surgery, an average of 2 hours
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Average Subject Time Spent on Cardiopulmonary Cross Clamp
Time Frame: At time of surgery, an average of 1.5 hours
Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Secondary Outcomes
- Subjects Who Received a Permanent Pacemaker Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects Who Experienced Major Bleeding Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.(Prior to Surgery)
- Subject's Average Mean Gradients (mmHg) Measurements Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects Who Required a Thoracic Resternotomy Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With Endocarditis Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Thromboembolism Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects Who Died Intraoperatively(Surgery)
- Subject's Effective Orifice Area (EOA) Measurement Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With a Major Paravalvular Leak (OPC) Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Cardiac Tamponade Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Amount of Aortic Valvular Regurgitation Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With Renal Failure Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Myocardial Infarction Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.(Baseline and 2 Years)
- Subject's Average Peak Gradients (mmHg) Measurements Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With a Cardiac Reoperation for Any Reason Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects Who Experienced Respiratory Failure Over Time(30 days, 3 Months , 6 Months, 1 Year, 2 Years.)
- Subjects With a Deep Sternal Would Infection Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Health Care Utilization(Day of surgical procedure through discharge from the hospital, an average of 2 weeks)
- Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)