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Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement

NCT03965065 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2020-02-20

No results posted yet for this study

Summary

Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of:

* 6 -month hemodynamic performance.
* 6 month clinical outcomes including all cause mortality, stroke, myocardial infarction, valve reoperation and major/life threatening bleeding
* Cost effectiveness

Conditions

  • Heart Valve Prosthesis
  • Aortic Stenosis
  • Hemodynamics

Interventions

DEVICE

Sutureless aortic bioprosthesis

Patients will receive a sutureless aortic bioprosthesis

DEVICE

Conventional stented sutured aortic prosthesis

Patients will receive a stented sutured aortic prosthesis

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Manuel Carnero, MD, PhD · Hospital Clinico San Carlos. Madrid. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-02
Primary Completion
2020-05-30
Completion
2020-05-30

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 NCT03965065 on ClinicalTrials.gov