CompletedNot Applicable

COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

United States26 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range5 Years

SexALL

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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

✕. 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

What they're measuring

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

Timeframe: 1-year post-implant

Trial details

NCT IDNCT02656290

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2020-03-04

View on ClinicalTrials.gov More Pulmonary Valve Insufficiency trials