No registrations found.
ID
Source
Health condition
Structural heart disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is clinical feedback on workflow, usability, and clinical impact of the device
Secondary outcome
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
This evaluation investigates the workflow improvements, usability, and potential clinical impact of new software solutions to be used in the planning of and/or during structural heart disease interventions. Qualitative feedback of the software usage will be collected in order to understand how well the software supports and improves the current percutaneous intervention. Also, patient demographics, procedure time, contrast usage and adverse events will be collected for comparison to historical data.
Study objective
This evaluation does not have a hypothesis to be tested since it is intended to evaluate the workflow and usability of the new software solution, without prior defined performance criteria.
Study design
The total duration of the study is expected to take approximately 24 months.
Intervention
The study will be conducted as per standard of care for the implantable devices indicated for patients.
The following procedure steps are additional to standard of care:
- Pre- and peri-interventional planning and verification using multimodality imaging
- Image-based guidance of catheters and devices on a separate display window
After the procedure is finished, the patient will leave the study.
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
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6836 |
| NTR-old | NTR7073 |
| CCMO | NL63726.100.17 |
| OMON | NL-OMON44552 |