This study is aimed at evaluate whether the microTEE can be used in stead of the current TEE probe, or intracardiac ultrasound catheters (ICE) in adults with a structural heart disease. The aim of the study is to compare image quality, the workflow…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this clinical study is:
• to establish that microTEE can view the same required anatomical features as
TEE and ICE for their respective purposes.
Secondary outcome
The secondary objectives are:
• to establish that microTEE can be used without the use of general anesthesia
• to establish that transnasal use of a S8-3t microTEE probe is feasible
• to collect anonymised X-ray fluoroscopy and microTEE data for prototype
development of fused X-ray and echography imaging
Background summary
In recent years there has been a strong increase in the number of innovative
percutaneous cardiac interventions for the treatment of patients with
structural heart disease. These interventions allows the treatment of patients
who previously were at too high risk for a surgical operation.
Echocardiography using TEE or ICE imaging are crucial for guiding these
procedures. Recently, a microTEE probe for transesophageal imaging in children
has become available.
This study is evaluating whether the microTEE can be used in place of the
current TEE probe, or intra-cardiac ultrasound catheters (ICE) in adult with a
structural heart disease.
The use of the microTEE probe may have the following advantages compared to the
current TEE probe or ICE:
- The MicroTEE probe is much smaller than the current TEE probe which is less
invasive and risks to patient are lower.
- Less invasive than intracardiac echo because venapuncture is no longer
necessary
- Because the probe smaller / less invasive, it is expected that the probe is
better tollerated and general anaesthesia might not be necessary anymore with
less risks for the patient and cost-saving.
- The MicroTEE can be reused which is costsaving compared to the disposable
catheters used in ICE.
Study objective
This study is aimed at evaluate whether the microTEE can be used in stead of
the current TEE probe, or intracardiac ultrasound catheters (ICE) in adults
with a structural heart disease.
The aim of the study is to compare image quality, the workflow and the ability
to visualize the probe using the MicroTEE various cardiac structures and to
compare it with the current standard (TEE or ICE). Anonimized images will be
saved to use for a prototype software for the fusion of X-ray and ultrasound
images.
Study design
Patients who are scheduled to undergo a procedure concerning structural heart
disease will be contacted if prior to the procedure additional recordings with
the MicroTEE probe can be made. After this procedure will be carried out with
the guidance of TEE or ICE in the usual way
Intervention
Additional recordings with MicroTEE probe prior to the scheduled procedure
which is currently guided by TEE or ICE will be made
Study burden and risks
Minimal burden and risk for the patient. Prior to the study only a few images
with MicroTEE probe will be made before the initiation of the planned procedure
which is currenlty guided by TEE or ICE imaging. Patients are in the majority
of cases under general anesthesia so there is no burden in these patients. In
patients who do not receive general anesthesia we will examine if the microTEE
probe is well tolerated.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
• Subjects who will be undergoing a cardiac intervention where routinely TEE or ICE imaging is used
• Subjects who will be subject to a procedure where atrial transseptal puncture is required
• Subjects who will undergo a LAA (left atrial appendage) closure procedure
• Subjects who will undergo a PFO (patent fossa ovalis) closure procedure
• Subject who are 18 years of age or older
• Subject who will give informed consent to participate in the study
Exclusion criteria
• Subject is younger that 18 years of age
• Subjects who will not give informed consent to participate in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL49744.100.14 |
OMON | NL-OMON22253 |