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OpenTrials
Completed

NCT Number: NCT00475267

Aortic Valve Replacement With Trifecta(TM)

The purpose of this study is 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

University of British Columbia, St. Paul's Hospital, Vancouver, British Columbia, Canada

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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

Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.

Primary outcomes

  1. Characterize patient NYHA functional classification status.

    Time frame: At required follow-up intervals

  2. Characterize the hemodynamic performance of the valve.

    Time frame: At required follow-up intervals

  3. Establish adverse event rates.

    Time frame: Ongoing

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 4, 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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