Long Term Follow Up Study of the St. Jude Medical Trifecta Valve

Overview

About this study

The purpose of this study is to collect long term follow up study data of the Trifecta valve in subjects who had the Trifecta valve implanted during the IDE study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Currently has a Trifecta valve that was implanted
Met eligibility criteria prior to enrollment in the Trifecta IDE study
Agrees to complete all required follow-up visits
Provided written informed consent prior to any study related procedure as approved by the governing Institutional Review Board or the Ethics Committee of the investigational site

Exclusion Criteria

Is currently participating or planning to participate in any other study unless approved by St Jude Medical

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Hartzell Schaff, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Hartzell Schaff, M.D.

Closed for enrollment

More information

Publications

To evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve. Read More on PubMed
The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve. Read More on PubMed

Clinical Trials