Brief Title
An Observational, Prospective Evaluation of the Trifecta™ Valve
Official Title
An Observational, Prospective Evaluation of the Trifecta™ Valve
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.
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
Primary Outcome
To characterize patient NYHA functional classification status
Condition
Aortic Valve Insufficiency
Intervention
Trifecta aortic heart valve
Study Arms / Comparison Groups
Trifecta Valve
Description: The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
120
Start Date
November 2007
Completion Date
December 2010
Primary Completion Date
July 2010
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Friedrich W Mohr, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00727181
Organization ID
CS05002TV
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Friedrich W Mohr, MD, Principal Investigator, Universitat Herzzentrum Leipzig GmbH
Verification Date
February 2019