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

NCT02656290 | Completed Results DMC FDA Device

• 1 other identifier: 2015-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Valve Insufficiency; Pulmonary Valve Degeneration; Congenital Pulmonary Valve Abnormality

Outcome Measures

Primary Outcomes (1)

• Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 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.

  1-year post-implant

Secondary Outcomes (11)

• Percentage of Early Adverse Events

  Percentage of events occurring within 30 days of procedure

• 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 Mean Gradient Measurements Over Time.

  Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

• Subject's Average Peak 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

Other Outcomes (9)

• Subject's Average White Blood Cell Count

  Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

• Subject's Average Red Blood Cell Count

  Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

• Subject's Average Hemoglobin Count

  Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Study Arms (1)

Edwards Pericardial Aortic Bioprosthesis Model 11000A

EXPERIMENTAL

Pulmonary valve replacement

Device: Edwards Pericardial Aortic Bioprosthesis Model 11000A

Interventions

Edwards Pericardial Aortic Bioprosthesis Model 11000A DEVICE

Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium

Edwards Pericardial Aortic Bioprosthesis Model 11000A

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Aya Westbrook, PhD, Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Aya_Westbrook@edwards.com

949-250-2500

Study Officials

• Christopher Baird, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: November 28, 2022
• Last Updated: November 21, 2023
• Results First Posted: March 17, 2020

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)