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 March 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01700439
First received: September 19, 2012
Last updated: March 12, 2014
Last verified: March 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

  Show 26 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

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: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Edwards Lifesciences:
Valve disorder
Valve disease
Aortic valve
Heart valve
Tissue valve
Bioprosthesis
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 Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014