Structural heart disease
Conditions
Interventions
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-intervention
Sponsors
Philips Medical Systems Nederland B.V.
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is clinical feedback on workflow, usability, and clinical impact of the device | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactCherif Sahyoun
Outcome results
None listed