Research with human participants

Overview of medical research in the Netherlands

Comparison between stented, stentless and transcatheter aortic valve bioprostheses using 4D flow magnetic resonance imaging

Published:
Last updated:

Compare hemodynamic parameters and flow patterns of the stented Mitroflow bioprosthesis, stentless Freedom SOLO bioprosthesis,transcatheter Edwards Sapien bioprosthesis and healthy control subjects, measured with 4D flow MRI.

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

ID

NL-OMON44677

Source

ToetsingOnline

Brief title

Aortic valve bioprostheses in 4D flow MR

Condition

  • Cardiac valve disorders

Synonym

aortic valve bioprostheses, prosthetic heart valve

Research involving

Human

Sponsors and support

Primary sponsor :
Academisch Medisch Centrum
Source(s) of monetary or material Support :
AMC

Intervention

Keyword :
4D flow, aortic valve, bioprostheses, MRI

Outcome measures

Primary outcome

maximum and average flow velocity, flow pattern and wall shear stress and

kinetic energy loss over the aortic valve

Secondary outcome

nvt

Background summary

When a patient needs an aortic valve replacement there are multiple heart valve
prostheses available. All have their pros and cons. De biological aortic valve
prosthesis increased tremendously the last decade. The disadvantage of the
biological prosthesis is its durability. The valves that represent the most
physiological flow will maybe be the most durable ones. Recently, 4D flow MRI
sequence has become available to assess flow patterns across heart valves in
multiple dimensions over time.

Study objective

Compare hemodynamic parameters and flow patterns of the stented Mitroflow
bioprosthesis, stentless Freedom SOLO bioprosthesis,transcatheter Edwards
Sapien bioprosthesis and healthy control subjects, measured with 4D flow MRI.

Study design

Pilot study

Study burden and risks

no risks
Scan takes 40 minutes, if possible planned during regular visit in outpatient
clinic

Public
Academisch Medisch Centrum

Meibergdreef 9
Amsterdam 1105 AZ
NL
Scientific
Academisch Medisch Centrum

Meibergdreef 9
Amsterdam 1105 AZ
NL

Listed location countries

Netherlands

Age

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

Inclusion criteria

Adult patients who had an aortic valve replacement with a Mitroflow or SOLO bioprotheses, or a transcatheter aortic valve implantation with an Edwards Sapien.

Exclusion criteria

Multiple valve replacements
Contraindication for MRI (see protocol for specification)

Design

Study type :
Observational non invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
60
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC

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 NL50502.018.14