An Observational, Prospective Evaluation of the Trifecta™ Valve

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence
• Intervention / Treatment: Device: Trifecta aortic heart valve

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Hôpital de Pontchaillou
• Germany
  • Leipzig, Germany, 04289
    • Universitat Herzzentrum Leipzig GmbH
  • München, Germany, 80636
    • Deutsches Herzzentrum München
• Netherlands
  • Amsterdam, Netherlands, 1091
    • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trifecta Valve; The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.	Device: Trifecta aortic heart valve; Replacement of a diseased, damaged, or malfunctioning aortic heart valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To characterize patient NYHA functional classification status	CE labelling
To characterize the hemodynamic performance of the valve, as per echocardiography	CE labelling
Safety outcomes	CE labelling

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Friedrich W Mohr, MD, Universitat Herzzentrum Leipzig GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): August 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cardiac surgery; bioprosthesis; aortic valve stenosis; aortic valve; heart valve; tissue valve; valve disorder; valve disease; aortic valve regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: CS05002TV