MedTrace Logo

SPAnish Aortic VALVE Multicentric Study

NCT03595423 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2018-07-23

No results posted yet for this study

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 regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B.

Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain

Conditions

  • Survival, Prosthesis
  • Prosthesis Durability
  • Valve Heart Disease

Interventions

PROCEDURE

Surgical AVR with bioprosthetic or mechanical prosthesis

Surgical AVR with bioprosthetic or mechanical prosthesis

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-03-31
Completion
2019-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595423 on ClinicalTrials.gov