The purpose of Part 1 of the research is to look at the usability and accuracy of the automatically determined CT visualizations and measurements.The purpose of Part 2 of the study is to determine whether the use of the combined information provides…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is clinical feedback on workflow, usability, and clinical
impact of the device:
1) Define critical anatomical structures, markers, anatomical views, and
measurements on CT and ultrasound required for mitral and other structural
heart disease procedures
2) Define critical overlay annotations for clinically significant guidance
3) Generate hypotheses on measurable impact parameters of imaging
Secondary outcome
Secondary endpoints include:
- Procedure time, radiation dose (DAP and AK), contrast agent used during
interventions
- Procedural parameters such as number of positioning attempts, complication
rates, adverse events, adverse device effects, device deficiencies that could
led to an SAE.
Background summary
Minimally invasive mitral valve interventions require complex CT planning and
intra-procedural imaging. The research software application facilitates the
processing and display of multimodal information to prepare and guide these new
complex procedures.
The Philips supporting visualizations for heart interventions consist of two
components:
1. Before the intervention, the Philips computer automatically finds the
heart's structures in the CT scan. These heart structures are visualized
together with automatic measurements. The attending cardiologist looks at the
CT images together with the supporting visualizations to prepare the
intervention.
2. During the intervention, CT, X-ray and echo images are cleverly combined
into one single image. By bringing all the data together, there is a better
image for the treating cardiologist.
Study objective
The purpose of Part 1 of the research is to look at the usability and accuracy
of the automatically determined CT visualizations and measurements.
The purpose of Part 2 of the study is to determine whether the use of the
combined information provides the cardiologist with additional information
compared to the standard transesophageal echo and standard x-ray images
separately. As a result, cardiac catheterisation may be easier.
The results of the study are used to optimize future commercial products.
Study design
This is a prospective, non-randomized, unblinded, observational, single-center
study.
Study burden and risks
There are no possible risks or additional direct benefits associated with
participation in this research compared with standard of care treatment.
Veenpluis 4-6
Best 5684PC
NL
Veenpluis 4-6
Best 5684PC
NL
Listed location countries
Age
Inclusion criteria
- Subjects undergoing an SHD procedure and/or
- Subjects undergoing SHD procedural planning
- Subject is 18 years of age or older
- Subject is able to give informed consent, or of legal age to give informed consent per national law
Exclusion criteria
- Subject unable or unwilling to sign informed consent
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Subject meets an exclusion criteria according to national law (e.g. Age, pregnant woman, breast feeding woman)
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 | NL63726.100.17 |
| OMON | NL-OMON29681 |