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An Observational, Prospective Evaluation of the Trifecta™ Valve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00727181
First received: July 29, 2008
Last updated: October 17, 2011
Last verified: October 2011

July 29, 2008
October 17, 2011
November 2007
July 2010   (final data collection date for primary outcome measure)
  • To characterize patient NYHA functional classification status [ Time Frame: CE labelling ] [ Designated as safety issue: No ]
  • To characterize the hemodynamic performance of the valve, as per echocardiography [ Time Frame: CE labelling ] [ Designated as safety issue: No ]
  • Safety outcomes [ Time Frame: CE labelling ] [ Designated as safety issue: Yes ]
  • To characterize patient NYHA functional classification status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To characterize the hemodynamic performance of the valve, as per echocardiography [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To establish adverse event rates as compared to a set of Objective Performance Criteria (OPC) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00727181 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Observational, Prospective Evaluation of the Trifecta™ Valve
An Observational, Prospective Evaluation of the Trifecta™ Valve

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Insufficiency
  • Regurgitation, Aortic Valve
  • Aortic Valve Incompetence
  • Aortic Valve Stenosis
Device: Trifecta aortic heart valve
Replacement of a diseased, damaged, or malfunctioning aortic heart valve
Trifecta Valve
The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.
Intervention: Device: Trifecta aortic heart valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands
 
NCT00727181
CS05002TV
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Friedrich W Mohr, MD Universitat Herzzentrum Leipzig GmbH
St. Jude Medical
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP