An Observational, Prospective Evaluation of the Trifecta™ Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727181
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.

Condition or disease Intervention/treatment Phase
Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence Aortic Valve Stenosis Device: Trifecta aortic heart valve Not Applicable

Detailed Description:
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observational, Prospective Evaluation of the Trifecta™ Valve
Study Start Date : November 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Trifecta Valve
The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.
Device: Trifecta aortic heart valve
Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Primary Outcome Measures :
  1. To characterize patient NYHA functional classification status [ Time Frame: CE labelling ]
  2. To characterize the hemodynamic performance of the valve, as per echocardiography [ Time Frame: CE labelling ]
  3. Safety outcomes [ Time Frame: CE labelling ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
  2. Patient is legal age in host country.
  3. Patient (or legal guardian) has given written informed consent for participation prior to surgery.
  4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

  1. Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
  2. Patient already has a prosthetic valve(s) at a site other than the aortic valve.
  3. Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
  4. Patient has an inability or is unwilling to return for the required follow-up visits.
  5. Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
  6. Patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery.
  7. Patient is undergoing renal dialysis.
  8. Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
  9. Patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period.
  10. Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
  11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
  12. Patient has a life expectancy less than two years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727181

Hôpital de Pontchaillou
Rennes, France, 35033
Universitat Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Deutsches Herzzentrum München
München, Germany, 80636
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Friedrich W Mohr, MD Universitat Herzzentrum Leipzig GmbH

Responsible Party: St. Jude Medical Identifier: NCT00727181     History of Changes
Other Study ID Numbers: CS05002TV
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by St. Jude Medical:
aortic valve
heart valve
tissue valve
valve disorder
valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction