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An Observational, Prospective Evaluation of the Trifecta™ Valve

Primary Purpose

Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Trifecta aortic heart valve

About this trial

This is an interventional treatment trial for Aortic Valve Insufficiency focused on measuring aortic valve, heart valve, tissue valve, bioprosthesis, valve disorder, valve disease, cardiac surgery, aortic valve stenosis, aortic valve regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Hôpital de Pontchaillou
Universitat Herzzentrum Leipzig GmbH
Deutsches Herzzentrum München
Onze Lieve Vrouwe Gasthuis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Trifecta Valve

Arm Description

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

Outcomes

Primary Outcome Measures

To characterize patient NYHA functional classification status

To characterize the hemodynamic performance of the valve, as per echocardiography

Safety outcomes

Secondary Outcome Measures

Full Information

NCT ID

NCT00727181

First Posted

July 29, 2008

Last Updated

February 1, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00727181

Brief Title

An Observational, Prospective Evaluation of the Trifecta™ Valve

Official Title

An Observational, Prospective Evaluation of the Trifecta™ Valve

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trifecta Valve

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Trifecta aortic heart valve

Intervention Description

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

Primary Outcome Measure Information:

Title

To characterize patient NYHA functional classification status

Time Frame

CE labelling

Title

To characterize the hemodynamic performance of the valve, as per echocardiography

Time Frame

CE labelling

Title

Safety outcomes

Time Frame

CE labelling

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich W Mohr, MD

Organizational Affiliation

Universitat Herzzentrum Leipzig GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital de Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Universitat Herzzentrum Leipzig GmbH

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Facility Name

Deutsches Herzzentrum München

City

München

ZIP/Postal Code

80636

Country

Germany

Facility Name

Onze Lieve Vrouwe Gasthuis

City

Amsterdam

ZIP/Postal Code

1091

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

An Observational, Prospective Evaluation of the Trifecta™ Valve

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