Status:
COMPLETED
An Observational, Prospective Evaluation of the Trifecta™ Valve
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
- Patient is legal age in host country.
- Patient (or legal guardian) has given written informed consent for participation prior to surgery.
- Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.
Exclusion
- Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
- Patient already has a prosthetic valve(s) at a site other than the aortic valve.
- Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
- Patient has an inability or is unwilling to return for the required follow-up visits.
- Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
- 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.
- Patient is undergoing renal dialysis.
- Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
- 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.
- Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
- Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- Patient has a life expectancy less than two years.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00727181
Start Date
November 1 2007
End Date
December 1 2010
Last Update
February 4 2019
Active Locations (4)
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1
Hôpital de Pontchaillou
Rennes, France, 35033
2
Universitat Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
3
Deutsches Herzzentrum München
München, Germany, 80636
4
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091