N/A
N=26
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Pulmonary Valve Insufficiency · Pulmonary Valve Degeneration · Congenital Pulmonary Valve Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT02656290 ↗Enrolled (actual)
26
Serious AEs
38.5%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. — 100.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Edwards Pericardial Aortic Bioprosthesis Model 11000A (Device)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant. |
100.0 | — |
| SECONDARY Percentage of Early Adverse Events |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. |
0.0; 0.0; 0.0; 13.7; 2.3; 11.4 | — |
| SECONDARY Subject's Average Mean Gradient Measurements Over Time. |
8.0; 9.0; 8.4; 7.7; 7.8; 9.5 | — |
| SECONDARY Subject's Average Peak Gradient Measurements Over Time. |
15.6; 16.1; 16.4; 13.7; 13.6; 17.0 | — |
| SECONDARY Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size |
1; 3; 8; 10; 0; 0 | — |
| SECONDARY Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size |
0; 0; 0; 0; 1; 3 | — |
| SECONDARY Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. |
21.5; 36.2; 28.8; 30.8; 25.2; 31.6 | — |
| SECONDARY Subject's Average Peak Velocity Measurement Over Time |
2.0; 1.8; 2.0; 1.8; 1.8; 2.1 | — |
| SECONDARY Subject's Average Doppler Velocity Index (DVI) |
0.7; 0.6; 0.6; 0.5; 0.5; 0.7 | — |
| SECONDARY Subject's Average Transvalvular Velocity Time Interval (VTI) |
70.2; 82.9; 76.5; 77.8; 69.0; 73.9 | — |
| SECONDARY Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class |
0; 10; 0; 0; 16; 0 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02656290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.