Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

Edwards Lifesciences1 site in 1 country26 target enrollmentDecember 2015

ConditionsPulmonary Valve Insufficiency Pulmonary Valve Degeneration Congenital Pulmonary Valve Abnormality

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Valve Insufficiency
Sponsor: Edwards Lifesciences
Enrollment: 26
Locations: 1
Primary Endpoint: Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

November 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Exclusion criteria:
•A subject meeting any of the following criteria shall be excluded:
•Valve-in-conduit procedure
•Requires emergency surgery
•Has acute myocardial infarction (MI) within 30 days prior to screening date
•Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to screening date
•Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.

Time Frame: 1-year post-implant

Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.

Secondary Outcomes

Percentage of Early Adverse Events(Percentage of events occurring within 30 days of procedure)
Subject's Average Mean Gradient Measurements Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size(Discharge, 30 days, 3 months, and annually thereafter for up to 5 years)
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.(Events occurring ≥ 31 days and up through 5 years post implant.)
Subject's Average Peak Gradient Measurements Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Subject's Average Doppler Velocity Index (DVI)(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Subject's Average Peak Velocity Measurement Over Time(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Subject's Average Transvalvular Velocity Time Interval (VTI)(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size(Discharge, 30 days, 3 months, and annually thereafter for up to 5 years)