An Observational, Prospective Evaluation of the Trifecta™ Valve

Aortic Valve Stenosis Clinical Trial

Official title:

An Observational, Prospective Evaluation of the Trifecta™ Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727181
• Other study ID #: CS05002TV
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Incompetence
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Regurgitation, Aortic Valve

Intervention

Device:
• Trifecta aortic heart valve
Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Locations

Country	Name	City	State
France	Hôpital de Pontchaillou	Rennes
Germany	Universitat Herzzentrum Leipzig GmbH	Leipzig
Germany	Deutsches Herzzentrum München	München
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize patient NYHA functional classification status		CE labelling
Primary	To characterize the hemodynamic performance of the valve, as per echocardiography		CE labelling
Primary	Safety outcomes		CE labelling