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Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve

NCT03346044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2017-11-17

No results posted yet for this study

Summary

The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark".

Specific objectives will be to determine structural failure and valve explantation rates, thromboembolic events and mortality rates for each valve.

Haemodynamic assessments will also be made using echocardiography to measure gradients across the valves and changes in left ventricular function and wall thickness.

Conditions

  • Cardiac Valve Replacement

Interventions

DEVICE

Carpentier-Edwards SAV bioprostheses

Performance of these bioprostheses

DEVICE

Medtronic Mosaic bioprostheses

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • Jonathan Unsworth-White, BSc FRCS · University Hospital Plymouth NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-01
Primary Completion
2006-02-02
Completion
2016-01-12

Countries

  • United Kingdom

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 NCT03346044 on ClinicalTrials.gov