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.
ID
Bron
Aandoening
Structural heart disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is clinical feedback on workflow, usability, and clinical impact of the device
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
The total duration of the study is expected to take approximately 24 months.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6836 |
| NTR-old | NTR7073 |
| CCMO | NL63726.100.17 |
| OMON | NL-OMON44552 |