NCT00727181

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

July 29, 2008

Last Update Submit

February 1, 2019

Conditions

Aortic Valve InsufficiencyRegurgitation, Aortic ValveAortic Valve IncompetenceAortic Valve Stenosis

Keywords

aortic valveheart valvetissue valvebioprosthesisvalve disordervalve diseasecardiac surgeryaortic valve stenosisaortic valve regurgitation

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Trifecta Valve

OTHER

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

Device: Trifecta aortic heart valve

Interventions

Trifecta aortic heart valveDEVICE

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

Trifecta Valve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital de Pontchaillou

Rennes, 35033, France

Location

Universitat Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve InsufficiencyAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Friedrich W Mohr, MD

    Universitat Herzzentrum Leipzig GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

November 1, 2007

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

FR(1)DE(2)NL(1)