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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:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01700439
First received: September 19, 2012
Last updated: October 25, 2016
Last verified: October 2016

September 19, 2012
October 25, 2016
September 2012
August 2016   (final data collection date for primary outcome measure)
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 primary safety endpoints consist of: All cause mortality, Trial valve-related mortality, Thromboembolism, Valve thrombosis (trial valve), All hemorrhage, Major hemorrhage, All paravalvular leak (trial valve), Major paravalvular leak (trial valve), Endocarditis (trial valve), Structural valve deterioration (trial valve), Non-Structural valve deterioration (trial valve), Valve Malposition, Valve Migration/ embolization, Valve Instability, Valve Dislodgment, Hemolysis, Reoperation, Trial valve-related reoperation, Explant, Trial valve explant, Implant-related new or worsened cardiac conduction disturbance, requiring permanent pacemaker implant not requiring permanent pacemaker implant.
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.
Complete list of historical versions of study NCT01700439 on ClinicalTrials.gov Archive Site
  • New York Heart Association (NYHA) Class [ Time Frame: Time Frame: Baseline and one year follow-up ] [ Designated as safety issue: No ]
    New York Heart Association (NYHA) functional class (I, II, III, IV) at one year will be compared to baseline assessment.
  • Hemodynamic performance [ 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 ]
    Mean gradient (mmHg) and peak gradient (mmHg) will be evaluated by echocardiography at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Hemodynamic performance [ 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 ]
    Effective orifice area [EOA] (cm2) will be evaluated by echocardiography at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Hemodynamic performance [ 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 ]
    Effective orifice area [EOA] index (cm2/m2) and performance index (cm2/m2) will be evaluated by echocardiography at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Hemodynamic performance [ 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 ]
    Cardiac output [CO] (L/min) will be evaluated by echocardiography at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Hemodynamic performance [ 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 ]
    Cardiac index (L/min/m2), will be evaluated by echocardiography at 3, 6, 12 months and annually thereafter from post implant.
  • Hemodynamic performance [ 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 ]
    Valvular regurgitation (including paravalvular leak) (Scale = None, Trace, Mild, Moderate, Severe) will be evaluated by echocardiography at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Heart Valve Device Technical Success [ Time Frame: Time Frame: Day of procedure ] [ Designated as safety issue: No ]
    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.
  • Patient procedural success [ Time Frame: Time Frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first. ] [ Designated as safety issue: No ]
    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.
  • Surgical and hospitalization factors [ Time Frame: Time Frame: Day of procedure through discharge ] [ Designated as safety issue: No ]
    Cross-clamp time (minutes/hours), Cardiopulmonary bypass time (minutes/hours) and the length of time (minutes/hours) the patient spends in the intensive care unit (ICU) will be recorded.
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.
  • Quality of life survey at one year compared to baseline [ Time Frame: Time Frame: Baseline and one year follow-up ] [ Designated as safety issue: No ]
    The following outcome for additional evaluation will be the change in Short Form 12 version 1 (SF-12v2) Quality of Life questionnaire from Baseline to 1 year.
  • Laboratory analysis [ 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 ]
    White Blood Cell Count (103/uL) and platelet Count (103/uL) will be evaluated at screening and at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Laboratory analysis [ 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 ]
    Red Blood Cell Count (106/uL) will be evaluated at screening and at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Laboratory analysis [ 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 ]
    Hematocrit (%) will be evaluated at screening and at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Laboratory analysis [ 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 ]
    Hemoglobin (mg/dL), Plasma-free Hemoglobin (mg/dL) or Haptoglobin (mg/dL) will be evaluated at screening and at discharge, 3, 6, 12 months and annually thereafter from post implant.
  • Laboratory analysis [ 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 ]
    Serum lactate dehydrogenase (U/L) will be evaluated at screening and at discharge, 3, 6, 12 months and annually thereafter from post implant.
Not Provided
 
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Aortic Valve Stenosis With Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence
Device: EDWARDS INTUITY valve
Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
Experimental: EDWARDS INTUITY valve
All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
Intervention: Device: EDWARDS INTUITY valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
950
September 2018
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01700439
2011-02
Yes
Not Provided
Not Provided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Glenn Barnhart, MD Swedish Medical Center
Principal Investigator: Walter Randolph Chitwood, MD East Carolina University
Edwards Lifesciences
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP