SPAnish Aortic VALVE Multicentric Study (SPAVALVE)

July 11, 2018 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Retrospective Multicentric Study Spanish SPALVALVE: Follow-up to 15 Years of Patients Between 50-65 Years Undergoing Isolated Aortic Valve Replacement. Biological or Mechanical Prostheses

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (early 30-day death, stroke, any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography,, and degree of significant structural degeneration in bioprostheses.

Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in 30 centers with a Cardiovascular Surgery Dept. in SPAIN as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and infective endocarditis.

Survival analysis and clinical data records will be performed through the Public Health Care computed medical records , and direct telephone contact with family and / or relatives, in case of doubts. A crude analysis of the data and a posterior analysis by propensity score matching with SPSS or R software will be carried out using a 1: 1 or 2:1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 5000 cases is expected, of which about 1000 would be bioprostheses that would serve as a basis for the pairing. According to previous data(ANDALVALVE STUDY), to find a 4.8% difference in the primary endpoint, two groups of 1025 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Subanalysis will be performed by subgroups of age (50-55 vs. 55-65 years) and another according to the mark of the 2 prostheses of each type most implanted. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA or Private biostatistics. Competing risks analysis will be performed to calculate the cumulative incidence of stroke, reoperation and major bleeding for each prosthesis type.

Conclusions: A positive result (similar survival in group B, with lower complications) could change the current indications of AVR in our environment, allowing the age of indication for bioprostheses in European guidelines to be reduced below 60 years

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
        • Contact:
        • Principal Investigator:
          • EMILIANO RODRIGUEZ-CAULO, MD, PHD
        • Sub-Investigator:
          • JOSÉ M MELERO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis implantation

Description

Inclusion Criteria:

  • Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive

Exclusion Criteria:

  • Not reported Residency change (unreachable)
  • Need of concomitant surgery
  • Reoperations
  • Infective endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bioprosthesis
All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive.
Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis
Surgical AVR with bioprosthetic or mechanical prosthesis
Mechanical prosthesis
All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive.
Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis
Surgical AVR with bioprosthetic or mechanical prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants alive
Time Frame: From date of surgery until the date of death from any cause, assessed up to 18 years
Survival since surgery
From date of surgery until the date of death from any cause, assessed up to 18 years
Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications
Time Frame: From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 18 years
Early 30-day Mortality, major bleeding, stroke and need of any prosthesis reoperation
From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of stroke at 15 years between groups
Time Frame: From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years
stroke cumulative incidence over time (competing risk analysis)
From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of prosthesis reoperation at 15 years between groups
Time Frame: From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years
reoperation cumulative incidence over time (competing risk analysis)
From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of major bleeding at 15 years between groups
Time Frame: From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years
major bleeding cumulative incidence over time (competing risk analysis)
From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Anticipated)

March 31, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPAVALVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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