ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01757665
First received: December 18, 2012
Last updated: May 21, 2014
Last verified: May 2014

December 18, 2012
May 21, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
Safety Endpoints [ Time Frame: When 400 patient years for each valve position has been achieved - approx. December 2016 ] [ Designated as safety issue: Yes ]

Descriptive information of early rates and late linearized rates of:

  • Structural valve deterioration
  • Thromboembolism
  • Valve thrombosis
  • All bleeding/hemorrhage
  • Major bleeding/hemorrhage
  • All paravalvular leak
  • Major paravalvular leak
  • Non-structural valve deterioration
  • Endocarditis
  • All cause mortality
  • Trial valve-related mortality
  • Trial valve-related reoperation
  • Explant
  • Hemolysis
Safety Endpoints [ Time Frame: When 800 late patient years has been achieved - Up to 3 years ] [ Designated as safety issue: Yes ]

Descriptive information of early rates and late linearized rates of:

  • Structural valve deterioration
  • Thromboembolism
  • Valve thrombosis
  • All bleeding/hemorrhage
  • Major bleeding/hemorrhage
  • All paravalvular leak
  • Major paravalvular leak
  • Non-structural valve deterioration
  • Endocarditis
  • All cause mortality
  • Trial valve-related mortality
  • Trial valve-related reoperation
  • Explant
  • Hemolysis
Complete list of historical versions of study NCT01757665 on ClinicalTrials.gov Archive Site
Effectiveness Endpoints [ Time Frame: Up to 5-Years at each scheduled follow-up visit ] [ Designated as safety issue: No ]
  • Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
  • New York Heart Association (NY-HA) functional class compared to baseline
  • Change in Quality of Life questionnaire Short Form 12 version 2 (SF-12v2) from baseline/screening to POD 390
Effectiveness Endpoints [ Time Frame: Up to 5-Years at each scheduled follow-up visit ] [ Designated as safety issue: No ]
  • Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
  • New York Heart Association (NY-HA) functional class compared to baseline
  • Change in Quality of Life question-naire Short Form 12 version 2 (SF-12v2) from baseline/screening to POD 390
Not Provided
Not Provided
 
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of the Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 650 subjects will be enrolled at up to 35 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Stenosis
  • Mitral Stenosis
  • Aortic Valve Insufficiency
  • Mitral Valve Insufficiency
  • Heart Failure
Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M
Experimental: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
Aortic/Mitral valve replacement therapy
Intervention: Device: Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
December 2020
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Is 18 years or older
  2. Provides written informed consent prior to trial procedures
  3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the COMMENCE trial and/or obtain the protocol-specified diagnostic tests at centers that are under the same IRB
  4. Diagnosed with aortic or mitral valve disease requiring valve replacement based on pre- operative evaluation
  5. Scheduled to undergo planned aortic or mitral valve replacement with or without concomitant bypass surgery
  6. Scheduled to undergo planned aortic valve replacement with or without resection and replacement of the ascending aorta from the sinotubular junction and without the need for circulatory arrest for hemi arch or arch replacement

Exclusion criteria:

  1. Requires emergency surgery
  2. Requires multiple valve replacement/ repair
  3. Has prior valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
  4. Requires a surgical procedure outside of the cardiac area (e.g. vascular bypass)
  5. Requires surgical replacement of the aortic root
  6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months to the scheduled aortic or mitral valve replacement surgery
  7. Has renal insufficiency as determined by creatinine (S-Cr) level ≥ 2.5 mgdL or end-stage renal disease requiring chronic dialysis at screening visit
  8. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months (180 days) prior to planned valve surgery
  9. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery
  10. Has presence of non-cardiac disease limiting life expectancy to less than 12 months
  11. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
  12. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
  13. Exhibits left ventricular ejection fraction ≤ 20% as validated by diagnostic procedure prior to planned valve surgery
  14. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
  15. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
  16. Documented leukopenia (WBC < 3.5x 103/µL), acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), thrombocytopenia (platelet count < 50x103/µL) or history of bleeding diathesis or coagulopathy
  17. Has prior organ transplant or is currently an organ transplant candidate
  18. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
  19. Was previously implanted with trial device (Model 11000A or Model 11000M)
  20. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in trial
  21. Currently incarcerated or unable to give voluntary informed consent
  22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
  23. Requires concomitant left ventricular assist device (LVAD) placement
Both
18 Years and older
No
Contact: Bruce Van Deman 949-250-2626 bruce_van_deman@ewards.com
Contact: Gita Ghadimi, OD 949-250-5872 gita_ghadimi@edwards.com
United States,   Poland
 
NCT01757665
2012-02
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: John Puskas, MD Emory University Hospital Midtown
Principal Investigator: Lars Svensson, MD,PhD Organizational Affiliation: The Cleveland Clinic
Edwards Lifesciences
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP