Clinical trial NCT01757665: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
Official title: ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Mitral Stenosis
Aortic Valve Insufficiency
Mitral Valve Insufficiency
Heart Failure
Keywords: Aortic valve replacement
Mitral valve replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 777
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. 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.

Eligibility criteria: Eligibility Criteria:

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 or the same healthcare system
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:

A subject meeting any of the following criteria shall be excluded:

1. Requires emergency surgery
2. Requires planned multiple valve replacement/ repair (with the exception of mitral valve replacement with tricuspid valve 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 mg/dL 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 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) or thrombocytopenia (platelet count \< 50x 10³/μL) accompanied by history of bleeding diathesis and 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

Primary outcomes:
measure: Subjects With Structural Valve Deterioration
timeFrame: 1 Year Post Implant
Secondary outcomes:
measure: Percentage of Subjects With Early Adverse Events
timeFrame: Events occuring within 30 days of procedure
measure: Percentage of Late Adverse Events Divided by Late Patient Years
timeFrame: Events occurring >= 31 days and up through 3 years post-implant
Other outcomes:
measure: Subject's Average Mean Gradient Measurements - 11000A
timeFrame: 3 Months, 1 Year, and 2 Year Post Implant
measure: Subject's Average Mean Gradient Measurements - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Peak Gradients Measurements Over Time - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Peak Gradients Measurements Over Time - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Effective Orifice Area Measurements - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Effective Orifice Area Measurements - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Performance Index Measurements - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Performance Index Measurements - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Cardiac Output Over Time - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Cardiac Output Over Time - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Cardiac Index Over Time- 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Cardiac Index Over Time - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Amount of Total Valvular Regurgitation Over Time - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Amount of Total Valvular Regurgitation Over Time - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Amount of Paravalvular Leak Over Time - 11000A
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Amount of Paravalvular Leak Over Time - 11000M
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
timeFrame: 3 Months, 1 Year, and 2 Years Post Implant
measure: Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
timeFrame: Baseline and one year post-implant
measure: Subject's Average White Blood Cell Count
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Red Blood Cells Count
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Hematocrit Percentage
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Hemoglobin Count
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Platelet Count
timeFrame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years
measure: Subject's Average Plasma Free Hemoglobin
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average International Normalized Ratio
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Partial Thromboplastin Time
timeFrame: Baseline, Discharge, 3 Months, 1 Year and 2 Year
measure: Subject's Average Prothrombin Time
timeFrame: Baseline, Discharge, 3 Months, 1 Year, and 2 Years
measure: Subjects Average Serum Glycerol Levels
timeFrame: Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Stanford
country: United States
facility: Board of Trustees of the Leland Stanford Junior University
state: California
city: New Haven
country: United States
facility: Yale-New Haven
state: Connecticut
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University/ Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: New York Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Mechanicsburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas Health
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital of Baylor Plano
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: John Puskas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
citation: Johnston DR, Griffith BP, Puskas JD, Bavaria JE, Svensson LG; COMMENCE Trial Investigators. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg. 2021 Nov;162(5):1478-1485. doi: 10.1016/j.jtcvs.2020.01.095. Epub 2020 Feb 21.
citation: Bavaria JE, Griffith B, Heimansohn DA, Rozanski J, Johnston DR, Bartus K, Girardi LN, Beaver T, Takayama H, Mumtaz MA, Rosengart TK, Starnes V, Timek TA, Boateng P, Ryan W, Cornwell LD, Blackstone EH, Borger MA, Pibarot P, Thourani VH, Svensson LG, Puskas JD; COMMENCE Trial Investigators. Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue. Ann Thorac Surg. 2023 Jun;115(6):1429-1436. doi: 10.1016/j.athoracsur.2021.12.058. Epub 2022 Jan 20.
citation: Heimansohn DA, Baker C, Rodriguez E, Takayama H, Dagenais F, Talton DS, Mumtaz MA, Pibarot P, Puskas JD; COMMENCE Trial Investigators. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. JTCVS Open. 2023 Jun 2;15:151-163. doi: 10.1016/j.xjon.2023.05.008. eCollection 2023 Sep.
citation: Beaver T, Bavaria JE, Griffith B, Svensson LG, Pibarot P, Borger MA, Sharaf OM, Heimansohn DA, Thourani VH, Blackstone EH, Puskas JD; COMMENCE Trial Investigators. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791. doi: 10.1016/j.jtcvs.2023.09.047. Epub 2023 Sep 29.
citation: Bavaria JE, Mumtaz MA, Griffith B, Svensson LG, Pibarot P, Borger MA, Thourani VH, Blackstone EH, Puskas JD. Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis. Ann Thorac Surg. 2024 Jul;118(1):173-179. doi: 10.1016/j.athoracsur.2023.11.036. Epub 2023 Dec 21.
citation: Thourani VH, Puskas JD, Griffith B, Svensson LG, Pibarot P, Borger MA, Heimansohn D, Beaver T, Blackstone EH, Antonio ALM, Bavaria JE; COMMENCE Trial Investigators. Five-year comparison of clinical and echocardiographic outcomes of pure aortic stenosis with pure aortic regurgitation or mixed aortic valve disease in the COMMENCE trial. JTCVS Open. 2024 Sep 10;22:160-173. doi: 10.1016/j.xjon.2024.08.020. eCollection 2024 Dec.