Clinical trial NCT02688153: EDWARDS INTUITY Valve System CADENCE Study
Official title: A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Aortic Stenosis
Keywords: Aortic Valve Replacement
Aortic Stenosis
EDWARDS INTUITY
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

* ≥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%

Primary outcomes:
measure: Average Subject Time Spent on Cardiopulmonary Cross Clamp
timeFrame: At time of surgery, an average of 1.5 hours
measure: Average Amount of Time Subject Spent on Cardiopulmonary Bypass
timeFrame: At time of surgery, an average of 2 hours
Secondary outcomes:
measure: Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
timeFrame: Baseline and 2 Years
measure: Subject's Average Mean Gradients (mmHg) Measurements Over Time.
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subject's Average Peak Gradients (mmHg) Measurements Over Time.
timeFrame: 30 days, 3 months, 6 months, 1 year, 2 year
measure: Subject's Effective Orifice Area (EOA) Measurement Over Time.
timeFrame: 30 days, 3 months, 6 months, 1 year, 2 year
measure: Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
timeFrame: 30 days, 3 months, 6 months, 1 year, 2 year
measure: Amount of Aortic Valvular Regurgitation Over Time.
timeFrame: 30 days, 3 months, 6 months, 1 year, 2 year
measure: Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
timeFrame: Prior to Surgery
measure: Subjects Who Required a Thoracic Resternotomy Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects Who Received a Permanent Pacemaker Over Time.
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Major Paravalvular Leak (OPC) Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects Who Experienced Major Bleeding Over Time.
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects Who Experienced Respiratory Failure Over Time
timeFrame: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.
measure: Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With Renal Failure Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With Endocarditis Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Deep Sternal Would Infection Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Myocardial Infarction Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Thromboembolism Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Cardiac Tamponade Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects With a Cardiac Reoperation for Any Reason Over Time
timeFrame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subjects Who Died Intraoperatively
timeFrame: Surgery
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
timeFrame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
timeFrame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
timeFrame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
measure: Health Care Utilization
timeFrame: Day of surgical procedure through discharge from the hospital, an average of 2 weeks
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux, Hôpital Haut-Lévêque
Study officials:
affiliation: CHU Bordeaux - Hôpital Haut-Lévèque
name: Prof. Labrousse, MD
role: PRINCIPAL_INVESTIGATOR
References: