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Bioprosthetic Valve

Edwards Pericardial Aortic Bioprosthesis Model 11000A for Congenital Pulmonary Valve Stenosis (COMMENCE-P Trial)

N/A
Waitlist Available
Led By Christopher Baird, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post-implant
Awards & highlights

COMMENCE-P Trial Summary

This trial is testing a new aortic valve for people 5+ who need to replace their native or prosthetic pulmonary valve.

Eligible Conditions
  • Congenital Pulmonary Valve Stenosis
  • Pulmonary Valve Regurgitation
  • Pulmonary Valve Stenosis

COMMENCE-P Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
Secondary outcome measures
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class
+8 more
Other outcome measures
Subject's Average Hematocrit Percentage
Subject's Average Hemoglobin Count
Subject's Average International Normalized Ratio (INR)
+6 more

COMMENCE-P Trial Design

1Treatment groups
Experimental Treatment
Group I: Edwards Pericardial Aortic Bioprosthesis Model 11000AExperimental Treatment1 Intervention
Pulmonary valve replacement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Edwards Pericardial Aortic Bioprosthesis Model 11000A
2015
N/A
~30

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,548 Total Patients Enrolled
Christopher Baird, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any vacancies for participants in this experiment?

"The clinicaltrials.gov website reveals that, although this trial was initially posted in December 2015 and last updated on March 4th 2022, it is no longer recruiting participants. However, there are currently 177 other studies actively enrolling patients at the present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
2015. "COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02656290.
~3 spots leftby Apr 2025
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