Aortic Valve Replacement With Trifecta(TM)

NCT00475709 | Completed Results DMC

• 1 other identifier: CS0501
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 18

Brief Summary

To confirm the clinical safety and effectiveness of the Trifecta valve.

Conditions

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

Keywords

aortic valve; heart valve; tissue valve; bioprosthesis; valve disorder; valve disease; cardiac surgery; aortic valve stenosis; aortic valve regurgitation

Outcome Measures

Primary Outcomes (3)

• Late Adverse Event Rates

  Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]

  Events occurring greater than or equal to 31 days post-implant.

• Characterize Patient NYHA Functional Classification Status.

  The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.

  1 year

• Characterize the Hemodynamic Performance of the Valve.

  Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.

  1 year

Study Arms (1)

Trifecta Aortic Heart Valve

EXPERIMENTAL

All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.

Device: Trifecta Aortic Heart Valve

Interventions

Trifecta Aortic Heart Valve DEVICE

Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.

Trifecta Aortic Heart Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
• Legal age.
• Signed informed consent prior to surgery.
• Willing to complete all follow-up requirements.

You may not qualify if:

• Pregnant or nursing women.
• Have already had a valve replaced other than the aortic valve.
• Needs another valve replaced.
• Cannot return for required follow-up visits.
• Have active endocarditis.
• Acute preoperative neurological event (such as a stroke).
• Renal dialysis.
• History of substance abuse within one year, or a prison inmate.
• Participating in another study.
• Life expectancy less than two years.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (18)

USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital

Los Angeles, California, 90033, United States

Location

Sarasota Memorial Hospital/Clinical Research Center

Sarasota, Florida, 34239, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mission Hospitals

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Main Line Health Heart Center

Wynnewood, Pennsylvania, 19096, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37212, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Limitations and Caveats

The SAEs reported are based on the Edmunds criteria noted in Edmunds LH, Clark RE, Cohn LH, Grunkemeier GL, Miller CM, Weisel RD. Guidelines for reporting Morbidity and Mortality after Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5.

Results Point of Contact

• Title: Kelly Erickson
• Organization: St Jude Medical

kaerickson@sjm.com

16517566580

Study Officials

• Hartzell Schaff, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2012
• Last Updated: February 19, 2019
• Results First Posted: March 11, 2014

Record last verified: 2019-02

Locations

US (18)