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Completed

NCT Number: NCT00475709

Aortic Valve Replacement With Trifecta(TM)

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

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Key information

Conditions

Aortic Valve Insufficiency Aortic Valve Disease Aortic Valve Incompetence Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Regurgitation, Aortic Valve Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trifecta aortic heart valve

Device

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

Primary outcomes

  1. Late Adverse Event Rates

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

    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]

  2. Characterize Patient NYHA Functional Classification Status.

    Time frame: 1 year

    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.

  3. Characterize the Hemodynamic Performance of the Valve.

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

An Observational, Prospective Evaluation of the Trifecta Valve

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
May 21, 2007
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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