Overview

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
Sponsor Edwards Lifesciences
Start date July 2011
End date December 2018
Trial size 200 participants
Trial identifier NCT01651052, 2010-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Aortic valve replacement therapy
heart valve surgery
Implant of an aortic valve, Model 11000

Primary Outcomes

Measure
Safety Endpoints
time frame: Intraoperative, discharge, 3 months, and annual scheduled follow-up visits (5 Years)

Secondary Outcomes

Measure
Performance Endpoints
time frame: 5-Years (at each scheduled follow-up visit)

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.