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

Edwards Lifesciences

Status: Completed

Conditions: Regurgitation, Aortic Valve; Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency; Aortic Valve Incompetence

Treatments: Device: EDWARDS INTUITY valve

Study type: Interventional

Funder types: Industry

Identifiers

NCT01700439

2011-02

Details and patient eligibility

About

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Full 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.

Enrollment: 934 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 replacement 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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934 participants in 1 patient group

EDWARDS INTUITY valve

Experimental group

Description:

All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.

Treatment:

Device: EDWARDS INTUITY valve