Aortic Valve DiseaseCADENCENCT02688153
EDWARDS INTUITY Valve System CADENCE Study
A study testing EDWARDS INTUITY and Stented aortic bioprostheses in people with Aortic Valve Disease and Aortic Stenosis, run by Edwards Lifesciences at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Stenosis
- What is being tested?
- EDWARDS INTUITY and Stented aortic bioprostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- aortic stenosis / mixed aortic stenosis and aortic insufficiency
- SAVR+CABG (1-4 distal anastomoses)
- Log. EuroSCORE ≥6
- NYHA Class ≥II
Who cannot join
- pure aortic insufficiency
- pre-existing prosthetic heart valve or ring
- congenital true bicuspid / unicuspid aortic valve
- LVEF <20%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
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.
Read the 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.
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Being tested
- EDWARDS INTUITY, Stented aortic bioprostheses
- Keywords
- Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDWARDS INTUITYDevice
Also called aortic stenosis, stenosis-based insufficiency, aortic valve replacement
To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG.
Stented aortic bioprosthesesDevice
Also called aortic stenosis, stenosis-based insufficiency, aortic valve replacement
In comparison to control valves available on the market.
| Study group | Role | What they receive |
|---|---|---|
| EDWARDS INTUITY | Active comparator | EDWARDS INTUITY Valve System, Model 8300A Receives: Device: EDWARDS INTUITY |
| Stented aortic bioprostheses | Active comparator | Stented aortic bioprostheses Receives: Device: Stented aortic bioprostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Subject Time Spent on Cardiopulmonary Cross Clamp
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.
Measured: At time of surgery, an average of 1.5 hours
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Measured: At time of surgery, an average of 2 hours
Secondary outcomes (25)
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
Measured: Baseline and 2 Years
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Measured: 30 days, 3 months, 6 months, 1 year, 2 year
Subject's Effective Orifice Area (EOA) Measurement Over Time.
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Measured: 30 days, 3 months, 6 months, 1 year, 2 year
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Measured: 30 days, 3 months, 6 months, 1 year, 2 year
Amount of Aortic Valvular Regurgitation Over Time.
Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Measured: 30 days, 3 months, 6 months, 1 year, 2 year
Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.
Measured: Prior to Surgery
Subjects Who Required a Thoracic Resternotomy Over Time
Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Received a Permanent Pacemaker Over Time.
Number of Subjects who received a Permanent Pacemaker shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Major Paravalvular Leak (OPC) Over Time
Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points.
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.
Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Experienced Major Bleeding Over Time.
Number of subjects who experienced Major Bleeding shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Experienced Respiratory Failure Over Time
Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.
Measured: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With Renal Failure Over Time
Number of subjects who experienced Renal (kidney) Failure shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With Endocarditis Over Time
Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Deep Sternal Would Infection Over Time
Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Myocardial Infarction Over Time
Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Thromboembolism Over Time
Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Cardiac Tamponade Over Time
Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Cardiac Reoperation for Any Reason Over Time
Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.
Measured: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Died Intraoperatively
Number of subjects who died during surgery.
Measured: Surgery
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Measured: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time
The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).
The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.
Measured: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.
Measured: Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Health Care Utilization
The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.
Measured: Day of surgical procedure through discharge from the hospital, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startOct 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Labrousse, MD, Principal investigator, CHU Bordeaux - Hôpital Haut-Lévèque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688153
- Sponsor's protocol ID
- 2011-11
- Acronym
- CADENCE
- Status last verified
- May 2018
- First submitted
- 14 Oct 2015
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
- ClinicalTrials.gov ID
- NCT02688153
- Acronym / sponsor ID
- CADENCE / 2011-11
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Aortic Valve Replacement, Aortic Stenosis, EDWARDS INTUITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDWARDS INTUITY | Active comparator | Device: EDWARDS INTUITYEDWARDS INTUITY Valve System, Model 8300A |
| Stented aortic bioprostheses | Active comparator | Device: Stented aortic bioprosthesesStented aortic bioprostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- aortic stenosis / mixed aortic stenosis and aortic insufficiency
- SAVR+CABG (1-4 distal anastomoses)
- Log. EuroSCORE ≥6
- NYHA Class ≥II
Key exclusion criteria (4 listed)
- pure aortic insufficiency
- pre-existing prosthetic heart valve or ring
- congenital true bicuspid / unicuspid aortic valve
- LVEF <20%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDWARDS INTUITYAlso: aortic stenosis, stenosis-based insufficiency, aortic valve replacementTo evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR \& CABG. | Device | EDWARDS INTUITY |
| Stented aortic bioprosthesesAlso: aortic stenosis, stenosis-based insufficiency, aortic valve replacementIn comparison to control valves available on the market. | Device | Stented aortic bioprostheses |
Primary outcome
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.
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.
25 secondary outcomes
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.
Time frame: Baseline and 2 Years
Subject's Average Mean Gradients (mmHg) Measurements Over Time.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subject's Average Peak Gradients (mmHg) Measurements Over Time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Subject's Effective Orifice Area (EOA) Measurement Over Time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Amount of Aortic Valvular Regurgitation Over Time.
Time frame: 30 days, 3 months, 6 months, 1 year, 2 year
Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.
Time frame: Prior to Surgery
Subjects Who Required a Thoracic Resternotomy Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Received a Permanent Pacemaker Over Time.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Major Paravalvular Leak (OPC) Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Experienced Major Bleeding Over Time.
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Experienced Respiratory Failure Over Time
Time frame: 30 days, 3 Months , 6 Months, 1 Year, 2 Years.
Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With Renal Failure Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With Endocarditis Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Deep Sternal Would Infection Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Myocardial Infarction Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Thromboembolism Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Cardiac Tamponade Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects With a Cardiac Reoperation for Any Reason Over Time
Time frame: 30 days, 3 Months, 6 Months, 1 Year, 2 Years.
Subjects Who Died Intraoperatively
Time frame: Surgery
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.
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.
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.
Health Care Utilization
Time frame: Day of surgical procedure through discharge from the hospital, an average of 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Short Form Health Survey (SF-12) with 12 questions to measure functional health and well-being of patient's quality of lifeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Labrousse, MD principal investigator
CHU Bordeaux - Hôpital Haut-Lévèque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDWARDS INTUITY and Stented aortic bioprostheses in people with Aortic Valve Disease and Aortic Stenosis, run by Edwards Lifesciences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Subject Time Spent on Cardiopulmonary Cross Clamp (time frame: At time of surgery, an average of 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.