Semi-automatic views contribute to the ease of use and efficiency of the procedure.
ID
Bron
Verkorte titel
Aandoening
Structural Heart Diseases (SHD)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of the study is a qualitative assessment of the usefulness, accuracy and contribution to efficiency of automated views as proposed by the Investigational Device.
Achtergrond van het onderzoek
The study investigates concept and feasibility of view automation for SHD interventions. The study will explore the contribution of semi-automatic views based procedural context, anatomy and device information on the ease of use and efficiency of the procedure.
Doel van het onderzoek
Semi-automatic views contribute to the ease of use and efficiency of the procedure.
Onderzoeksopzet
The patients will be participating in the trial for the duration of the procedure. No-follow-up is required per protocol.
Onderzoeksproduct en/of interventie
No interventions to the normal way of working in the protocol, study is observational. Patients will receive standard of clinical care.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Subject is a patient that requires SHD intervention for which routine fluoroscopy and TEE guidance is used, such as: transcatheter mitral and tricuspid therapies (TTMT), left atrial appendage closure (LAAC), trans catheter aortic valve replacement (TAVR). Subject is able to give informed consent and is 18 years of age or older, or of legal age to give
informed consent per state or national law.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Subjects who are unsuitable to accept TEE imaging during a structural heart disease intervention
Subject is an adult who lacks the capacity provide consent
Subject is in an emergency condition
Subject participates in a potentially confounding drug or device trial during the course of the study
All vulnerable subjects, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.
Subject is pregnant or breast feeding woman
Subject is Philips employee their family members residing with this Philips employee.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9468 |
| Ander register | Philips Medical Systems B.V. : D000785186rA |