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 range18 Years

SexALL

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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)
✕. congenital true bicuspid / unicuspid aortic valve
✕. requires emergency surgery or has had emergency surgery for any reason
✕. LVEF \<25%
✕. active endocarditis ≤ 6 months before the intended treatment
✕. acute MI ≤ 90 days before the intended treatment
✕. had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery

What they're measuring

Median Subject Time Spent on Cardiopulmonary Cross Clamp

Timeframe: At time of surgery; an average of 1 hour

Median Amount of Time Subject Spent on Cardiopulmonary Bypass

Timeframe: At time of surgery; an average of 1 hour

Trial details

NCT IDNCT02672553

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2018-08-13

View on ClinicalTrials.gov More Aortic Valve Disease trials