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
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Observational, Prospective Evaluation of the Trifecta™ Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00727181     History of Changes
Other Study ID Numbers: CS05002TV
Study First Received: July 29, 2008
Last Updated: October 17, 2011
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

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014