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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02688153 |
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Date of registration:
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14/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EDWARDS INTUITY Valve System CADENCE Study
CADENCE |
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Scientific title:
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A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02688153 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Prof. Labrousse, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Bordeaux - Hôpital Haut-Lévèque |
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Key inclusion & exclusion criteria
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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%
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aortic Stenosis
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Aortic Valve Disease
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Intervention(s)
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Device: Stented aortic bioprostheses
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Device: EDWARDS INTUITY
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Primary Outcome(s)
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Average Subject Time Spent on Cardiopulmonary Cross Clamp
[Time Frame: At time of surgery, an average of 1.5 hours]
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Average Amount of Time Subject Spent on Cardiopulmonary Bypass
[Time Frame: At time of surgery, an average of 2 hours]
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Secondary Outcome(s)
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Subject's Average Mean Gradients (mmHg) Measurements Over Time.
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
[Time Frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects Who Required a Thoracic Resternotomy Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With a Cardiac Reoperation for Any Reason Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With a Deep Sternal Would Infection Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With a Thromboembolism Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
[Time Frame: Prior to Surgery]
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Subjects Who Received a Permanent Pacemaker Over Time.
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
[Time Frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subject's Effective Orifice Area (EOA) Measurement Over Time.
[Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year]
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Health Care Utilization
[Time Frame: Day of surgical procedure through discharge from the hospital, an average of 2 weeks]
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Subjects With a Cardiac Tamponade Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
[Time Frame: Baseline and 2 Years]
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Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
[Time Frame: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects Who Died Intraoperatively
[Time Frame: Surgery]
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Subjects With Endocarditis Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With Renal Failure Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subject's Average Peak Gradients (mmHg) Measurements Over Time.
[Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year]
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Subjects Who Experienced Respiratory Failure Over Time
[Time Frame: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.]
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Subjects With a Major Paravalvular Leak (OPC) Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Subjects With a Myocardial Infarction Over Time
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Amount of Aortic Valvular Regurgitation Over Time.
[Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year]
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Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
[Time Frame: 30 days, 3 months, 6 months, 1 year, 2 year]
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Subjects Who Experienced Major Bleeding Over Time.
[Time Frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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