Research with human participants

Overview of medical research in the Netherlands

Long-Term Follow-Up of the Freestyle Stentless Bioprosthesis

Published:
Last updated:

To evaluate long-term outcome of the Freestyle bioprosthesis in the aortic position

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Cardiac valve disorders
Study type
Observational non invasive

ID

NL-OMON40663

Source

ToetsingOnline

Brief title

Freestyle Study

Condition

  • Cardiac valve disorders

Synonym

aortic root pathology, Aortic valve pathology

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Medtronic B.V.,Medtronic;Inc;Minneapolis;MN;Verenigde Staten

Intervention

Keyword :
Aortic Root, Freestyle, stenless bioprosthesis

Outcome measures

Primary outcome

Structural valve detoriation

Secondary outcome

Valve-related mortality

Valve related events (nonstructural valve dysfunction, valve thrombosis,

thromboembolism, hemorrhage, valve endocarditis)

Hemodynamic performance (effective orifice area, peak transvalvular gradient,

LV mass reduction)

Quality of life (physical health, mental health)

Background summary

Little information exists on long-term durability of the Freestyle
bioprosthesis as it requires sufficient follow-up. Al Leiden University Medical
Center, the Freestyle bioprosthesis is used since June 1993.

Study objective

To evaluate long-term outcome of the Freestyle bioprosthesis in the aortic
position

Study design

Investigator initiated single-center observational study

Study burden and risks

Minimal burden and no risks are expected.

Public
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333ZA
NL
Scientific
Leids Universitair Medisch Centrum

Albinusdreef 2
Leiden 2333ZA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Implantation of the Freestyle bioprosthesis in the LUMC

Exclusion criteria

Explantation of Freestyle bioprosthesis

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
250
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL49058.058.14