CompletedNot Applicable

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Poland133 participantsStarted 2011-07

Plain-language summary

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Who can participate

Age range18 Years

SexALL

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: * 18 years or older * Require replacement of aortic valve * Signed informed consent * Willing to return to study site for follow-up visits Exclusion Criteria: * Active endocarditis/myocarditis (\< 3 months) * Myocardial infarction (\< 30 days) * Renal insufficiency/ End-stage renal disease * Life expectancy (\< 1 year) * Requires multiple valve replacement/repair * Requiring emergent aortic valve surgery * Pregnant or lactating

What they're measuring

Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)

Timeframe: Events occurring within 30 days of procedure

Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)

Timeframe: Events occurring >= 31 days and up through 5 years post-implant

Trial details

NCT IDNCT01651052

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07

Results submitted2019-04-22

View on ClinicalTrials.gov More Aortic Valve Disorder trials