Trial Radar AI | ||
|---|---|---|
De klinische studie NCT07121907 (SAITO 1B) voor TAVI(Transcatheter Aortic Valve Implantation) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia (SAITO 1B)
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT07121907 (SAITO 1B) is een interventioneel studie bij TAVI(Transcatheter Aortic Valve Implantation) met de status nog niet rekruterend. De inclusie van 10 deelnemers start op 15 september 2025. De studie wordt geleid door Caranx Medical en de voltooiing is gepland op 15 februari 2026. Laatste update op ClinicalTrials.gov: 14 augustus 2025.
Beknopte samenvatting
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI. It works alongside conventional fluoroscopy, using real-time image analysis to provide precise anatomical landmarks. TAVIPILOT Software detects key anatomical structures, tracks valve positioning, and uses AI-based confidence indicators to assist in alignment. The software is compatible with approved C-arm imaging systems and specific catheter models.
The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.
Officiële titel
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI) in Australia
Aandoeningen
TAVI(Transcatheter Aortic Valve Implantation)Andere studie-ID's
- SAITO 1B
- 55004
NCT-ID
Startdatum (Werkelijk)
2025-09-15
Laatste update geplaatst
2025-08-14
Verwachte einddatum
2026-02-15
Inschrijving (Geschat)
10
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelExperimental: TAVR procedure with TAVIPILOT Software (investigational medical device) Use of the TAVIPILOT Software during the procedure | TAVR Using a Guidance Software TAVR procedure with TAVIPILOT augmented reality guidance software operating during the procedure, enabling clinicians to assess the live analysis and recommendations provided by the software. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Investigational device-related safety | The primary objective is to evaluate investigational device-related safety, including the occurrence of investigational device-related conversion to open-heart surgery, investigational device-related valve embolization. | Periprocedural |
Investigational device-related safety | The investigational device-related safety will also be assessed by verifying the absence of major technical malfunctions. | Periprocedural |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Device usability | Evaluate clinical usability, assessed through customized questionnaires measuring clinician satisfaction, perceived ease of use, and integration of the devices into the procedural workflow. | Periprocedural |
Geschiktheidscriteria
Leeftijd van deelnemers
Oudere volwassene
Minimumleeftijd
65 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Patients aged ≥65
- Indicated for transfemoral TAVR for severe aortic stenosis
Caranx MedicalCentraal Contactpersoon
Contact: Eric Sejor, MD, 0033673335594, [email protected]
Contact: Christophe Naz, [email protected]
Geen locatiegegevens beschikbaar