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15 Years Outcomes Following Bioprosthetic vs Mechanical Aortic Valve Replacement Between 50-65 Years

NCT03239509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2018-07-26

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 5 Cardiovascular Surgery Centers in Andalousia (south Spain)

Conditions

  • Surgery
  • Survival, Prosthesis
  • Valve Heart Disease

Interventions

PROCEDURE

bioprosthesis implantation between 2000-2015

Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass

PROCEDURE

mechanical prosthesis implantation between 2000-2015

Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • EMILIANO A RODRIGUEZ-CAULO, MD, PhD · FIMABIS, HOSPITAL VIRGEN DE LA VICTORIA DE MÁLAGA

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Spain

Study Locations

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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 NCT03239509 on ClinicalTrials.gov