Current Environment:

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.

Conditions

Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Congenital Pulmonary Valve Abnormality

Recruitment Status

Active, not recruiting

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.

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
Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to screening date
Has renal insufficiency as determined by creatinine (S-Cr) level ~ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
Has documented leukopenia (WBC < 3.5x 103/I-lL), acute anemia (Hgb <10.0 g/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50xl03/I-lL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior to screening date
Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
RVOT aneurysm unless treated during pulmonary valve replacement surgery
Has prior organ transplant or is currently an organ transplant candidate
Was previously implanted with INSPIRIS RESILIA Pulmonary valve
Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
Need for concomitant replacement of the aortic, mitral or tricuspid valves
Has presence of non-cardiac disease limiting life expectancy to less than 12 months
Is Currently or has recently participated (within 6 weeks) in another investigational drug or device trial
Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers, or planning to become pregnant within 1 year of study valve implant
Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
Currently incarcerated or unable to give voluntary informed consent
Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron

Patients with hypersensitivity to latex

Intra-Op Exclusion Criterion:

Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation

Intervention

Intervention Type

Intervention Name

Device

Edwards Pericardial Aortic Bioprosthesis Model 11000A

Phase

Not Applicable

Gender

All

Minimum Age

5 Years

Maximum Age

N/A

Download Date

March 15, 2022

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: