MAPEO DEL RITMO Y ADQUISICIÓN DE SEÑALES PARA EL ANÁLISIS DE DATOS (RHAPSODY) (RHAPSODY)
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Rhythmia Mapping System is designed for electroanatomical mapping in catheter ablation procedures by optimizing the need for speed and accuracy. The system is able to simultaneously acquire data from multiple electrodes. In addition, based on user-defined criteria, the system is able to efficiently acquire data over multiple cardiac beats. When used in conjunction with the Rhythmia Mapping Catheter, the system is able to acquire up to hundreds of points per minute leading to fast and detailed map creation.
Since its market release, physicians and users have gained experience with the Boston Scientific Rhythmia Mapping System in the human clinical setting. Improvements to the first generation system are in development and include new and improved software features and mapping algorithms to enhance the clinical operation. These new and improved software features and algorithms require leveraging clinical use data as part of the development and iteration process.
This study will evaluate the performance of potential next-generation software features in a low-risk clinical environment by streaming raw signals from a commercial Rhythmia Workstation during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial fibrillation, atrial tachycardias, and ventricular tachycardia. The data will be evaluated on a parallel investigational Rhythmia Workstation using prototype software features. These next-generation software features and algorithms will not be available to the physician during the case and will therefore have no diagnostic or therapeutic impact on the clinical case.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susan Hampson
- Número de teléfono: 5087285165
- Correo electrónico: Susan.Hampson@bsci.com
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Terminado
- University of Alabama at Birmingham
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Terminado
- St. Lukes Idaho Cardiology Associates
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Massachusetts
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Burlington, Massachusetts, Estados Unidos, 01805
- Terminado
- Lahey Clinic, Inc.
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New Hampshire
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Londonderry, New Hampshire, Estados Unidos, 03053
- Reclutamiento
- Cardiovascular Specialists of New England Research Foundation
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Contacto:
- Jennifer Driscoll, RN, BSN
- Correo electrónico: jennifer.driscoll@csofne.com
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Investigador principal:
- Jamie Kim, MD
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Manchester, New Hampshire, Estados Unidos, 03102
- Terminado
- Catholic Medical Center
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New Jersey
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Ridgewood, New Jersey, Estados Unidos, 07450-2736
- Terminado
- Valley Hospital
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MI
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Milan, MI, Italia, 20132
- Terminado
- Fondazione Centro San Raffaele
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Monaco, Mónaco, 98000
- Terminado
- Centre Hospitalier Princesse Grace
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
Descripción
Inclusion Criteria:
- Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
- Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
Exclusion Criteria:
- Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia
- Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)
- Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
- Active systemic infection or sepsis
- Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.
- Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
- Women who are pregnant or lactating
- Cardiac surgery within the past 90 days
- Acute myocardial infarction within 3 months
- Stable/unstable angina or ongoing myocardial ischemia
- Subjects with an active heart failure decompensation
- Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
- Congenital heart disease with or without corrective surgery that would complicate a mapping procedure
- Subjects having untreatable allergy to contrast media
- Vascular pathology or tortuosity precluding standard vascular access techniques
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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All Subjects
All subjects are included in this cohort and are treated with the Rhythmia Mapping System |
The Rhythmia Mapping System is a 3D electro-anatomical mapping system. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physician Feedback on Software Performance
Periodo de tiempo: 1 day- Procedure
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Physician Feedback on Software Performance |
1 day- Procedure
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas H McElderry, MD, University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 91087667
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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