Clinical Research Details
Title:
An Observational, Prospective Evaluation of the Trifecta Valve
Purpose:
This observational cohort study will assess the clinical safety and effectiveness of aortic valve replacement (using the Trifecta valve) by prospectively recording adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
Study Number:
200626022008
Number of Patients:
500
Elgibility:
To be entered into the study, the patient must: 1) require aortic valve replacement, 2) be 18 years of age or older, 3) give written informed consent for participation prior to surgery, and 4) be willing to undergo all study procedures and return for follow-up. A patient will be excluded if they: 1) are pregnant or nursing, 2) have a prosthestic valve in the tricuspid, mitral or pulmonic site, 3) have active endocarditis, 4) have had an acute neurological event within 30 days prior to surgery, 5) are on renal dialysis, 6) have a history of substance abuse in the previous year, 7) are currently a prison inmate, 8) are currently enrolled in an investigational drug or device study, 9) has significant other cardiovascular abnormality such as a dissection, or 10) has a life expectancy less than two years.
Treatment:
The study treatment is the replacement of the diseased aortic valve with the aortic valve under study.
Principal Investigator:
Mamdouh Bakhos, M.D.
Enrollment Phone:
(708) 327-2503