To determine the clinical value and impact of 3D TEE models for image guidance during SHD interventions in both a qualitative and quantitative approach: • Qualitative: do the models help in understanding the relation between the cardiac structures…
ID
Bron
Aandoening
Structural Heart Disease procedures: LAAC, TMVR and TAVI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint is a qualitative and quantitative assessment by comparing the distances between
annotations genered automatically by the model with manual annotated structures and/or validating the
position of the annotations by contrast enhanced X-ray angio or the location of X-ray opaque structures (e.g.
devices) on the X-ray image.
Doel van het onderzoek
To determine the clinical value and impact of 3D TEE models for image guidance during SHD interventions in both a qualitative and quantitative approach:
• Qualitative: do the models help in understanding the relation between the cardiac structures from echo and the projected X-ray fluoroscopy image to support imaging and device guidance
• Quantitative: by a comparative measurement of structures provided by the 3D model and manual placed annotations
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.
Publiek
Roberto Corti
Witellikerstrasse 40
Zurich 8032
Switzerland
Wetenschappelijk
Roberto Corti
Witellikerstrasse 40
Zurich 8032
Switzerland
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients that require one of the following SHD interventions for which routine fluoroscopy and TEE guidance is used: MitraClip placement on the mitral valve (TMVR), left atrial appendage closure (LAAC), trans catheter aortic valve implantation (TAVI)
• Subject 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)
-Patients who are unsuitable to accept TEE imaging during a SHD intervention, further descibed in the Clinical Research Plan.
-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
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5612 |
| NTR-old | NTR5718 |
| Ander register | Philips Medical Systems b.v. : DHF250438 |