Registre clinique d'échocardiographie intracardiaque Philips (ICE)
Registre d'échocardiographie intracardiaque (ICE) Philips (VeriSight)
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado
-
-
Illinois
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Chicago, Illinois, États-Unis, 60208
- Northwestern University
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
-
-
Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
Texas
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Austin, Texas, États-Unis, 78705
- Texas Cardiac Arrhythmia Research Foundation
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.
La description
Inclusion Criteria:
- 18 years of age and willing to provide written, dated and signed, informed consent
- Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)
Exclusion Criteria:
- Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
- If alternate access (as needed instead of femoral) is not viable
- Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Prospective Observational
Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance |
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Technical Success
Délai: During procedure
|
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure |
During procedure
|
|
Imaging Success
Délai: During procedure
|
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator |
During procedure
|
|
Clinical Success
Délai: During procedure
|
Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. |
During procedure
|
|
Number of Participants With Device-related Adverse Event Detection
Délai: Procedure through 48 hours or discharge, whichever is earlier
|
Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. |
Procedure through 48 hours or discharge, whichever is earlier
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Rashmi Ram, PhD, Philips Clinical and Medical Affairs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Maladies cardiaques
- Arythmies cardiaques
- Anomalies congénitales
- Anomalies cardiovasculaires
- Malformations cardiaques congénitales
- Malformations septales cardiaques
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Maladie de la valve aortique
- Accident vasculaire cérébral
- Fibrillation auriculaire
- Foramen ovale, brevet
- Malformations septales cardiaques, auriculaires
- Maladies des valves cardiaques
Autres numéros d'identification d'étude
- 2019_10745
- 2019 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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