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 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01700439
First received: September 19, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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
Device: EDWARDS INTUITY valve

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: April 2015 (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.
Device: EDWARDS INTUITY valve
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01700439

Contacts
Contact: Catherine Doorly catherine_doorly@edwards.com
Contact: Shawna Snodgrass, B.A, M.A. shawna_snodgrass@edwards.com

  Hide Study Locations
Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Msgana Tamrat    310-825-1407    mtamrat@mednet.ucla.edu   
Principal Investigator: Richard Shemin, MD         
Keck Hospital of University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Becky Lopez, RN    323-442-6226    bmlopez@surgery.usc.edu   
Contact: Leticia Vasquez-Caldera, BA    323-442-6225    Leticia.vasquez-caldera@med.usc.edu   
Principal Investigator: Vaughn Starnes, MD         
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Amy Perez, RN    949-764-4509    amy.perez@hoag.org   
Contact: Cathy Major, RN    949-764-1469    cathy.major@hoag.org   
Principal Investigator: Aidan A Raney, MD         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Sandra Brainerd, RN, BSN    916-453-4161    Sandra.Brainerd@DignityHealth.org   
Contact: Deirdre Harris, RN, BSN    916-733-6290    Deirdre.Harris@DignityHealth.org   
Principal Investigator: Allen Morris, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Beverly Mansker, RN    407-303-7556    Beverly.Mansker@flhosp.org   
Contact: Melissa Leonard, RN MBA CCRP    407-303-7556    melissa.leonard@flhosp.org   
Principal Investigator: Kevin Accola, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin, RN, BSN, CCRC    312-695-4067    ahuskin@nmh.org   
Principal Investigator: Patrick McCarthy, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mary Trovato, BS    617-632-7488    mtrovato@bidmc.harvard.edu   
Contact: Lauren Mills, RN    617-632-9228    lpmills@bidmc.harvard.edu   
Principal Investigator: Kamal Khabbaz, MD         
United States, Michigan
The University of Michigan Medical School Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nickole Carlson, RN,BSN,CCRP    734-232-4780    ngarvey@med.umich.edu   
Contact: Jessica Taylor, RN,BSN,MSN    734-936-9664    jestaylo@med.umich.edu   
Principal Investigator: G Michael Deeb, MD         
United States, Missouri
Washington University - Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kelly Koogler, RN, BSN    314-362-3043    kooglerk@wudosis.wustl.edu   
Contact: Joann Marsala, RN    314-747-4547    marsalai@wudosis.wustl.edu   
Principal Investigator: Ralph Damiano, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Sandra Corut    856-968-7366    corut-sandra@cooperhealth.edu   
Principal Investigator: Michael Rosenbloom, MD         
United States, New York
North Shore Long Island Jewish Health System Recruiting
Manhasset, New York, United States, 11030
Contact: Jason McGrade, PA    516-562-4489    JmcGrade@nshs.edu   
Contact: Lynda Jahn, ANP    516-562-2851    ljahn@nshs.edu   
Principal Investigator: Alan Hartman, MD         
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Patricia Ursomanno, Ph.D    212-263-1064    patricia.ursomanno@nyumc.org   
Contact: Annette Rabinovich, BA    212-263-7585    annette.rabinovich@nyumc.org   
Principal Investigator: Didier Loulmet, MD         
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801
Contact: Christina Riggsbee, RN    828-213-7033    Christina.Riggsbee@msj.org   
Contact: On-call Research Nurse    828-213-1327      
Principal Investigator: Mark Groh, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Victoria Sutton, CCRP,CRC II    919-668-2382    victoria.sutton@duke.edu   
Principal Investigator: Donald Glower, MD         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Malissa Harris, RN BSN CCRC    252-744-5287    harrismal@ecu.edu   
Contact: Brenda Akers, RN BSN    252-744-8482    akersbr@ecu.edu   
Principal Investigator: Alan P. Kypson, MD         
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Angela Hein, RN BSN CCRN    513-862-2877    angela_hein@trihealth.com   
Contact: Carol Krabbe, RN BSN CCRN    513-862-2877    Carol_Krabbe@trihealth.com   
Principal Investigator: J. Michael Smith, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kathy Sankovic, RN, CCRP    216-445-6916    sankovk@ccf.org   
Contact: Michelle Garcia, RN,BSN, CCRC    216-442-5234    GARCIAM1@ccf.org   
Principal Investigator: Joseph Sabik, MD         
United States, Pennsylvania
Pinnacle Health at Harrisburg Hospital Recruiting
Harrisburg, Pennsylvania, United States, 17010
Contact: Regina Hollister, RN    717-731-0101 ext 3152    rhollister@pinnaclehealth.org   
Contact: Anita Todd, RN    717-731-0101 ext 3002    atodd@pinnaclehealth.org   
Principal Investigator: Mubashir Mumtaz, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rohan Menon    412-609-6325    Rohan.Menon@uphs.upenn.edu   
Contact: Elizabeth K Walsh, RN    215-662-4289    Lisa.Walsh@uphs.upenn.edu   
Principal Investigator: Y Joseph Woo, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Enlow    412-647-1582    enlowms@upmc.edu   
Contact: Kristin Valchar    412-647-7271    valcharka@upmc.edu   
Principal Investigator: Vinay Badhwar, MD         
Principal Investigator: Thomas Gleason, MD         
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Charlotte Porter, RN, CNOR, CCRC    901-747-1262    charlotte@cvsclinic.com   
Principal Investigator: H Edward Garrett Jr., MD         
St. Thomas Health Recruiting
Nashville, Tennessee, United States, 37205
Contact: Jan Orga, RN    615-222-3083    JAN.ORGA@STH.ORG   
Contact: Nancy Grimes, RN    615-222-4356    ngrimes@sth.org   
Principal Investigator: Evelio Rodriguez, MD         
United States, Texas
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Tricia Snelus    972-566-6389    tsnelus@crsti.org   
Contact: Jill Fowler    972-566-6389    jfowler@crsti.org   
Principal Investigator: Todd M Dewey, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Cecile Mahoney    972-566-5617    cmahoney@crsti.org   
Contact: Jill Fowler    972-566-6389    jfowler@crsti.org   
Principal Investigator: William H Ryan, III, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Deborah Tinlin    206-215-2455    deborah.tinlin@swedish.org   
Contact: Tracie Granger    206-215-2466    tracie.granger@swedish.org   
Principal Investigator: Glenn R Barnhart, MD         
United States, Wisconsin
Aurora St Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Cheryl Zywicki, RN    414-385-2474    Cheryl.zywicki@aurora.org   
Contact: Jennifer Cooper, RN    414-385-2504    Jennifer.cooper@aurora.org   
Principal Investigator: Daniel O'Hair, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Glenn Barnhart, MD Swedish Medical Center
Principal Investigator: Walter Randolph Chitwood, MD East Carolina University
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01700439     History of Changes
Other Study ID Numbers: 2011-02
Study First Received: September 19, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Defects, Congenital
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 27, 2014