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An Observational, Prospective Evaluation of the Trifecta™ Valve
This study is currently recruiting participants.
Verified by St. Jude Medical, July 2008
Sponsored by: St. Jude Medical
Information provided by: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00727181
  Purpose

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 Intervention
Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
Device: Trifecta aortic heart valve

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Observational, Prospective Evaluation of the Trifecta™ Valve

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • To establish adverse event rates as compared to a set of Objective Performance Criteria (OPC) [ Time Frame: 5 years ] [ 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 ]

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727181

Contacts
Contact: Silvia Mora +3227746811 smora@sjm.com

Locations
Germany
Universitat Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Friedrich W Mohr, MD     + 49 341 865-1421     mohrf@medizin.uni-leipzig.de    
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Friedrich W Mohr, MD Universitat Herzzentrum Leipzig GmbH
  More Information

Responsible Party: Universitat Herzzentrum Leipzig GmbH ( Friedrich Wilhelm Mohr, M.D. )
Study ID Numbers: CS05002TV
Study First Received: July 29, 2008
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00727181  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Heart Diseases
Aortic Valve Insufficiency
Constriction, Pathologic
Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on January 14, 2009