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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700439
First Posted: October 4, 2012
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edwards Lifesciences
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) [ Time Frame: Events occurring ≥ 31 days and up through 2 years post-implant ]
    Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]


Secondary Outcome Measures:
  • Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success [ Time Frame: Day of procedure ]
    Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.

  • Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success [ Time Frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first. ]
    Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.

  • Average Amount of Time Subject Spent on Cardiopulmonary Bypass [ Time Frame: Day of procedure ]
    Surgical and hospitalization factors - Cardiopulmonary bypass time

  • Average Subject Time on Cardiopulmonary Cross Clamp [ Time Frame: Day of procedure ]
    Surgical and hospitalization factors - Cardiopulmonary cross clamp time

  • Average Number of Days Subjects Were in the Intensive Care Unit (ICU) [ Time Frame: Day of procedure through discharge from the hospital ]
    Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.

  • Subject's Percentage of Change at 1 Year From Baseline in New York Heart Association (NYHA) Class [ Time Frame: Baseline and one year follow-up ]

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.

    Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

    Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

    Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

    Symptoms of heart failure or the anginal syndrome may be present even at rest.


  • Subject's Average Gradient Measurements at 1 Year [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Mean and peak gradients evaluated by echocardiography

  • Subject's Effective Orifice Area (EOA) Measurement at 1 Year [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Effective Orifice Area (EOA) evaluated by echocardiography

  • Subject's Effective Orifice Area Index (EOAI) Measurement at 1 Year [ Time Frame: 1 year follow-up ]
    Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography

  • Subject's Performance Index Measurement at 1 Year [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Performance Index evaluated by echocardiography

  • Subject's Cardiac Output Measurement at 1 Year [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Cardiac Output evaluated by echocardiography

  • Subject's Cardiac Index Measurement at 1 Year [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Cardiac index evaluated by echocardiography

  • Amount of Aortic Valvular Regurgitation in Subjects at 1 Year by Valve Size [ Time Frame: 1 Year follow-up ]
    Hemodynamic performance - Aortic valvular regurgitation evaluated by echocardiography


Other Outcome Measures:
  • Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey [ Time Frame: Baseline and one year follow-up ]
    The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.

  • Subject's Average White Blood Cell Count at 1 Year [ Time Frame: 1 Year follow-up ]
    Laboratory analysis of White Blood Cell Count on blood drawn from subject.

  • Subject's Average Red Blood Cell Count at 1 Year [ Time Frame: 1 Year follow-up ]
    Laboratory analysis of Red Blood Cell Count of blood drawn from subject.

  • Subject's Average Hematocrit Percentage at 1 Year [ Time Frame: 1 Year follow-up ]
    Laboratory analysis of Hematocrit of blood drawn from subject.

  • Subject's Average Hemoglobin Percentage at 1 Year [ Time Frame: 1 Year follow-up ]
    Laboratory analysis of Hemoglobin of blood drawn from subject.

  • Subject's Average Plasma Free Hemoglobin at 1 Year [ Time Frame: 1 Year follow-up ]
    Laboratory Analysis of Plasma Free Hemoglobin of blood drawn from subject.


Enrollment: 934
Study Start Date: September 2012
Estimated Study Completion Date: November 2021
Primary Completion Date: August 12, 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.
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 replacement 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 thereafter for a minimum of five years.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700439


  Show 29 Study Locations
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

Additional Information:
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01700439     History of Changes
Other Study ID Numbers: 2011-02
First Submitted: September 19, 2012
First Posted: October 4, 2012
Results First Submitted: September 22, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017

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

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