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

Completed · Not applicable

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

In brief

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

Key facts

Study ID

NCT01700439

Run by

Edwards Lifesciences

People needed

934

Starts

2012-09-26

Expected to finish

2021-05-26

Last updated by the study team

2023-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria - Subjects will be required to meet all inclusion criteria:
• Male or female, age 18 years or older
• Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation
• Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
• Provide written informed consent
• Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

You may not qualify if…

• Exclusion Criteria - Subjects will not be eligible for trial participation if any of the following criteria are present:
• Pure aortic insufficiency
• Requires emergency surgery
• Previous aortic valve replacement
• 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
• Requires multiple valve replacement/repair
• Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal)
• Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
• Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery
• Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery
• Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis
• Hyperparathyroidism
• MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure
• Presence of non-cardiac disease limiting life expectancy to less than 12 months
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Left ventricular ejection fraction ≤ 25%
• Documented history of substance (drug or alcohol) abuse within the last 5 years
• Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
• Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure
• Pregnancy, lactation, or planning to become pregnant;
• Currently incarcerated or unable to give voluntary informed consent
• 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
• History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)
• Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial
• Intra-operative Exclusion Criteria

Where it is running

• 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

Full record on ClinicalTrials.gov

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