Status:
COMPLETED
15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions:
Surgery
Survival, Prosthesis
Eligibility:
All Genders
50-65 years
Brief Summary
Currently there is an increase in the use of bioprosthesis worldwide (\> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence r...
Detailed Description
Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (death of any cause, neurological events (TIA / stroke), any prosthesis reoperat...
Eligibility Criteria
Inclusion
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive
Exclusion
- Not reported Residency change (unreachable)
- Need of concomitant surgery
- Reoperations
- Infective endocarditis
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03239509
Start Date
January 1 2017
End Date
April 1 2018
Last Update
July 26 2018
Active Locations (7)
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1
Hospital Regional Universitario de Malaga
Málaga, Málaga, Spain
2
Hospital Universitario Puerta Del Mar
Cadiz, Spain
3
Hospital Universitario Reina Sofia
Córdoba, Spain
4
Hospital Universitario Virgen de Las Nieves
Granada, Spain