Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
This trial is active, not recruiting.
|Conditions||aortic valve disorder, aortic valve insufficiency, aortic valve stenosis, heart failure, coronary artery disease|
|Treatment||heart valve surgery|
|Start date||July 2011|
|End date||December 2018|
|Trial size||200 participants|
|Trial identifier||NCT01651052, 2010-03|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Aortic valve replacement therapy
time frame: Intraoperative, discharge, 3 months, and annual scheduled follow-up visits (5 Years)
time frame: 5-Years (at each scheduled follow-up visit)
Male or female participants at least 18 years old.
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
|Official title||Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000|
|Principal investigator||Jerzy Sadowski, MD|
|Description||This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.|
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