Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Heart Valve Diseases Clinical Trial

Official title:

Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514162
• Other study ID #: 1003
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: October 2014

Study information

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

Clinical Trial Summary

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Description:

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.

• Subject met eligibility criteria of IDE study

• Subject agrees to complete study follow-up visits

• Subject provides written informed consent

Exclusion Criteria:

• Subject currently participating in another device or drug study

• Subject unable or unwilling to return for study follow-up visits

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• Trifecta valve
surgical replacement of aortic valve

Locations

Country	Name	City	State
United States	Mission Hospital	Asheville	North Carolina
United States	Abbott Northwestern Hospital Cardiac Surgical Associates	Minneapolis	Minnesota
United States	Intermountain Heart & Lung Surgical Associates	Murray	Utah
United States	Vanderbilt Heart Institute	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

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 Incidence	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]	5 years
Secondary	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.	5 years
Secondary	Report 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.	5 years