Aortic Valve Replacement With Trifecta(TM)

Aortic Valve Stenosis Clinical Trial

Official title:

An Observational, Prospective Evaluation of the Trifecta Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475709
• Other study ID #: CS0501
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: January 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: January 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aortic Valve Incompetence
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Regurgitation, Aortic Valve

Intervention

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

Locations

Country	Name	City	State
United States	Mission Hospitals	Asheville	North Carolina
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	NYU Medical Center	New York	New York
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sarasota Memorial Hospital/Clinical Research Center	Sarasota	Florida
United States	Main Line Health Heart Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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