Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:
• Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
• Is greater than or equal to 5 years of age
• Subject and/or subject's legal representative has provided written informed consent as approved and required by the respective institutional review board and agrees to its provisions. NOTE: Written consent must be obtained prior to any research related test being performed.
Locations
United States
Massachusetts
Boston Children's Hospital
Boston
Time Frame
Start Date: 2015-12
Completion Date: 2022-11-28
Participants
Target number of participants: 26
Treatments
Experimental: Edwards Pericardial Aortic Bioprosthesis Model 11000A
Pulmonary valve replacement
Authors
Sponsors
Leads: Edwards Lifesciences