EDWARDS INTUITY Valve System CADENCE-MIS Study (NCT02672553) | Clinical Trial Compass
CompletedNot Applicable
EDWARDS INTUITY Valve System CADENCE-MIS Study
Germany100 participantsStarted 2012-05
Plain-language summary
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. adult male or female ≥18 years of age
. symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
. EuroSCORE \<20
. NYHA Class ≥II
. Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
. Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
Exclusion criteria
. pure aortic insufficiency
. previous cardiac surgery (involved FS or MIS approach)
. requires emergency surgery or has had emergency surgery for any reason
. LVEF \<25%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Subject Time Spent on Cardiopulmonary Cross Clamp
Timeframe: At time of surgery; an average of 1 hour
2
Median Amount of Time Subject Spent on Cardiopulmonary Bypass
Timeframe: At time of surgery; an average of 1 hour