An Observational, Prospective Evaluation of the Trifecta™ Valve

NCT ID: NCT00727181

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trifecta Valve

The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.

Group Type: OTHER

Trifecta aortic heart valve

Intervention Type: DEVICE

Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Interventions

Trifecta aortic heart valve

Replacement of a diseased, damaged, or malfunctioning aortic heart valve

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Friedrich W Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

Universitat Herzzentrum Leipzig GmbH

Locations

Hôpital de Pontchaillou

Rennes, , France

Universitat Herzzentrum Leipzig GmbH

Leipzig, , Germany

Deutsches Herzzentrum München

München, , Germany

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Countries

France; Germany; Netherlands

Other Identifiers

CS05002TV

Identifier Type: -

Identifier Source: org_study_id