Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

NCT ID: NCT01700439

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 934 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-26
• Study Completion Date: 2021-05-26

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EDWARDS INTUITY valve

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

Group Type: EXPERIMENTAL

EDWARDS INTUITY valve

Intervention Type: DEVICE

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Interventions

EDWARDS INTUITY valve

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Intervention Type: DEVICE

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Barnhart, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Walter Randolph Chitwood, MD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Locations

Keck Hospital of University of Southern California

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University

Palo Alto, California, United States

Mercy General Hospital

Sacramento, California, United States

Florida Hospital

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

The University of Michigan Medical School

Ann Arbor, Michigan, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

North Shore Long Island Jewish Health System

Manhasset, New York, United States

New York University Medical Center

New York, New York, United States

Columbia University

New York, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

St. Thomas Health

Nashville, Tennessee, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.

Reference Type: RESULT

PMID: 27817951 (View on PubMed)

Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.

Reference Type: RESULT

PMID: 29705366 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2011-02

Identifier Type: -

Identifier Source: org_study_id