None listed
Conditions
Brief summary
The primary purpose of the study is to provide investigators with the information necessary to carry out a clinical evaluation of the SJM Epic Valve. In doing so the study will collect information to establish the adverse effect rates, clinical status as indicated by NYHA functional classification and hemodynamic performance.
Interventions
This study aims at confirming the clinical safety and efficacy of the St Jude Medical Epic porcine valve by establishing: the adverse effect rates, clinical staus as indicated by the New York Heart Association (NYHA) functional classification and hemodynamic performance.
Once a patient has met all the inclusion/exclusion criteria and signed consent: the patients malfunctioning Aortic or Mitral valve will be removed and replaced with the SJM Epic Valve.
Participants will undergo safety tests incl
This study aims at confirming the clinical safety and efficacy of the St Jude Medical Epic porcine valve by establishing: the adverse effect rates, clinical staus as indicated by the New York Heart Association (NYHA) functional classification and hemodynamic performance. Once a patient has met all the inclusion/exclusion criteria and signed consent: the patients malfunctioning Aortic or Mitral valve will be removed and replaced with the SJM Epic Valve. Participants will undergo safety tests including bloods, Echocardiogram, Hypertension etc during Enrollment, discharge, post operative visits: 6 month and 12 month. The SJM EPIC valve is manufactured from selected porcine aortic valve cusps that have been cross-linked with glutaraldehyde solution. The Valve is suspended on a holder which is secured to the valve with sutures. Depending on the surgeon and the case a surgical procedure will generally take between 2-6hours.
Sponsors
St. Jude Medical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
- The patient requires replacement of the aortic and/or mitral valve -The patient has signed a study specific informed consent agreeing to the data collection and follow-up requirements - The patient is of legal age in host country
Exclusion criteria
- Patient already has a prosthetic valve, other than an aortic and/or mitral valve being replaced at this occasion - Patient requries replacement of tricuspid valve or pulmonary valve - The Patient is pregnant - The patient has acticve endocarditis - Patient is undergoing renal dialysis - The patient has had an acute preoperative neurological event - the paitient is an intravenous drug abuser, alcoholic or prison inmate
Outcome results
None listed