Status:
COMPLETED
Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Aortic Heart Valve Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Since the first implant in September 1982, the Medtronic Hancock® II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations ...
Eligibility Criteria
Inclusion
- Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair.
- Patients who are able to provide informed consent.
Exclusion
- Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair.
- Patients indicated for receiving a mechanical prosthesis.
- Patients who will have a replacement of existing valve prosthesis.
- Patients refusing or not able to provide informed consent.
- Patients requiring emergency surgery.
- Patients unable to participate in follow-up
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01213615
Start Date
August 1 2008
End Date
May 1 2014
Last Update
October 30 2015
Active Locations (5)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
2
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Italy, 81100
3
Azienda Universitaria S. Maria della Misericordia
Udine, Italy, 33100
4
Leiden University Medical Center
Leiden, Netherlands, 2300 RC