Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences Identifier:
First received: September 19, 2012
Last updated: July 5, 2016
Last verified: July 2016
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Condition Intervention
Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Resource links provided by NLM:

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Long term Performance: Clinically acceptable function by echocardiogram [ Time Frame: All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 mo., 3 mo., 1 yr and annually thereafter thru 5 yr follow-up per subject. ] [ Designated as safety issue: Yes ]
    The safety endpoints consist of mortality, valve thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, structural and non-structural valve deterioration, explant, hemolysis, re-operation, and implant related new or worsening of a cardiac conduction issue.

Secondary Outcome Measures:
  • Hemodynamic performance assessed by echocardiogram [ Time Frame: All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 mo., 3 mo., 1 yr and annually thereafter thru 5 yr follow-up per subject. ] [ Designated as safety issue: No ]
    Effectiveness endpoints consists of device technical success, cross-clamp time, cardiopulmonary bypass time, length of time in the intensive care unit, NYHA functional class compared to baseline, and hemodynamic performance of the heart valve device confirmed by echocardiography.

Estimated Enrollment: 950
Study Start Date: September 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EDWARDS INTUITY valve
All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Detailed Description:
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually the-reafter for a minimum of five years.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

    1. Male or female, age 18 years or older
    2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replace-ment as indicated in the preoperative evaluation
    3. Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
    4. Provide written informed consent
    5. Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Exclusion Criteria:

  • Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:

    1. Pure aortic insufficiency
    2. Requires emergency surgery
    3. Previous aortic valve replacement
    4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ
    5. Requires multiple valve replacement/repair
    6. Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
    7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
    8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
    9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
    10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
    11. Hyperparathyroidism
    12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
    13. Presence of non-cardiac disease limiting life expectancy to less than 12 months
    14. Hypertrophic obstructive cardiomyopathy (HOCM)
    15. Left ventricular ejection fraction ≤ 25%
    16. Documented history of substance (drug or alcohol) abuse within the last 5 years
    17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
    18. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
    19. Pregnancy, lactation, or planning to become pregnant;
    20. Currently incarcerated or unable to give voluntary informed consent
    21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy
    22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
    23. Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial


      Intra-operative Exclusion Criteria

    24. Anatomic variances which contraindicate implant of the trial valve, such as:

      1. anomalous coronary arteries
      2. annular deformation or extensive calcification of the annulus or aortic root which cannot be removed
      3. significant calcium on the anterior mitral leaflet
      4. pronounced septal calcification
      5. position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow
    25. Available devices are not suitably sized for the subject's annulus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01700439

Contact: Catherine Doorly
Contact: Shawna Snodgrass, B.A, M.A.

  Hide Study Locations
United States, California
Keck Hospital of University of Southern California Active, not recruiting
Los Angeles, California, United States, 90033
University of California Los Angeles Active, not recruiting
Los Angeles, California, United States, 90095
Hoag Memorial Hospital Presbyterian Active, not recruiting
Newport Beach, California, United States, 92663
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Fidelis F Sabalvaro, CCRP    650-498-1232   
Principal Investigator: Y. Joseph Woo, MD         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Sandra Brainerd, RN, BSN    916-453-4161   
Contact: Deirdre Harris, RN, BSN    916-733-6290   
Principal Investigator: Allen Morris, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Tracy Purvis, RN, BN    407-303-5600 ext 1102019   
Contact: Theresa Sessions, RN, MSN CHRC    (407) 303-7556 ext 1102019   
Principal Investigator: Kevin Accola, MD         
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
The University of Michigan Medical School Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University - Barnes Jewish Hospital Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital Active, not recruiting
Camden, New Jersey, United States, 08103
United States, New York
North Shore Long Island Jewish Health System Active, not recruiting
Manhasset, New York, United States, 11030
New York University Medical Center Active, not recruiting
New York, New York, United States, 10016
Columbia University Active, not recruiting
New York, New York, United States, 10032
United States, North Carolina
Mission Hospital Active, not recruiting
Asheville, North Carolina, United States, 28801
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27705
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Good Samaritan Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45220
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pinnacle Health at Harrisburg Hospital Recruiting
Harrisburg, Pennsylvania, United States, 17010
Contact: Regina Hollister, RN    717-731-0101 ext 3152   
Contact: Anita Todd, RN    717-731-0101 ext 3002   
Principal Investigator: Mubashir Mumtaz, MD         
Hospital of the University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Baptist Memorial Hospital Active, not recruiting
Memphis, Tennessee, United States, 38120
St. Thomas Health Active, not recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Medical City Dallas Hospital Active, not recruiting
Dallas, Texas, United States, 75230
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
The Heart Hospital Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
United States, Washington
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
United States, Wisconsin
Aurora St Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Glenn Barnhart, MD Swedish Medical Center
Principal Investigator: Walter Randolph Chitwood, MD East Carolina University
  More Information

Responsible Party: Edwards Lifesciences Identifier: NCT01700439     History of Changes
Other Study ID Numbers: 2011-02 
Study First Received: September 19, 2012
Last Updated: July 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Edwards Lifesciences:
Aortic valve
Heart valve
Tissue valve
Valve disorder
Valve disease
Cardiac surgery
Less invasive cardiac surgery
Aortic valve stenosis
Aortic valve regurgitation
Bovine pericardium

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Defects, Congenital
Heart Valve Diseases
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on August 25, 2016