Clinical trial NCT00727181: An Observational, Prospective Evaluation of the Trifecta™ Valve
Official title: An Observational, Prospective Evaluation of the Trifecta™ Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
Keywords: aortic valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To characterize patient NYHA functional classification status
timeFrame: CE labelling
measure: To characterize the hemodynamic performance of the valve, as per echocardiography
timeFrame: CE labelling
measure: Safety outcomes
timeFrame: CE labelling
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Hôpital de Pontchaillou
city: Leipzig
country: Germany
facility: Universitat Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
Study officials:
affiliation: Universitat Herzzentrum Leipzig GmbH
name: Friedrich W Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References: