The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial (HALT)
14 de enero de 2022 actualizado por: Wilson Burke, Holy Cross Hospital, Florida
The Holding Area LINQ Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial Designed to Occur in the Holding Area of a Hospital Operating Room or Cardiac Catheterization/Electrophysiology Laboratory
The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in conducting impant procedures in the holding area of a hospital operating room vs cardiac catheterization/electrophysiology laboratory.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The Holding Area LINQ Trial is a prospective, non-randomized, single center post-market clinical trial designed to occur in the holding area of a hospital operating room or cardiac catheterization/electrophysiology laboratory.
The primary objective is to characterize the rate of procedure-related complications within 90 days of the implant procedure which require resolution by surgical intervention.
Twenty (20) patients with established clinical indications for the LINQ ICM (Reveal LINQ Insertable Cardiac Monitor) will be implanted using standard of care techniques and procedures.
Implants will be required to take place in a hospital holding area rather than the traditional facility locations such as the hospital operating room, cardiac catheterization lab, or electrophysiology lab.
A physical description of the holding area is a small patient examination room separated from other patient exam bay by walls and a door.
There is a sink in the patient exam room, laminate flooring, ceiling A/C vent, wall mounted Hemodynamic monitoring equipment, and wall mounted oxygen/suction lines.
Patient sedation will be limited to local anesthetics and/or oral anti-anxiety medications.
Intravenous access will be obtained only for emergency resuscitative measures.
Due to the low complication rate for this type of implant and practical limitations on the sample size, there are no formal hypotheses tested in this trial.
This study will characterize all procedure-related adverse events that occur within 90 days of the implant procedure.
Data will be collected at implant, 7-10 day post-op visit, and 90-day post-implant visits.
Tipo de estudio
De observación
Inscripción (Actual)
20
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33308
- Jim Moran Heart and Vascular Research Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
Descripción
Inclusion Criteria:
- Patient is indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
- Patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of Valium or Ativan) at patient request.
- Patient is 18 years of age or older.
- Patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.
Exclusion Criteria:
- Patient has reduced immune function or is otherwise at high risk for infection
- Patient has had a recent (within 30 days) or otherwise unresolved infection.
- Patient is implanted or indicated for implant with a pacemaker, Implantable Cardiac Device (ICD), Cardiac Resyncronization Therapy (CRT) or hemodynamic monitoring system.
- Patient is participating in another clinical trial that may have an impact on the trial endpoints.
- Patient has a super-therapeutic INR > 3.0.
- Patient considered by Principal Investigator and/or sub-investigator to be inappropriate for the trial for any reason.
- Patient's life expectancy is less than 1 year.
- Patient is pregnant.
- Patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
- Inability to comply with planned trial procedures
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
Periodo de tiempo: 90 days post-implant.
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-For this study there is no formal hypothesis or performance criterion tested for this objective.
Instead, the rate of these complications will be characterized by computing a point estimate and one-sided upper 95% confidence interval for the rate of procedure-related complications requiring surgical intervention 90 days post-implant-
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90 days post-implant.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cost-effectiveness for LINQ ICM holding area implants.
Periodo de tiempo: 90 days Post Implant
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Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form.
This information will be summarized using summary statistics and/or graphical methods.
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90 days Post Implant
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Device functionality post-implant through patient trial exit visit.
Periodo de tiempo: 90 Days Post Implant
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Device functionality post-implant will be characterized by collecting R-wave amplitudes on the day of implant and at the 90-day follow-up visit.
Following each implant, R-wave amplitude will be collected and recorded on the Implant e-CRF.
In addition, R-wave amplitude will be collected and recorded at the 90-day follow-up visit or at an unscheduled visit should the patient exit the study prior to the 90-day follow-up visit.
Summary statistics and/or graphical methods will be used to summarize the R-wave amplitude.
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90 Days Post Implant
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Resource utilization for LINQ ICM holding area implants.
Periodo de tiempo: 90 Days Post Implant
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Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form.
This information will be summarized using summary statistics and/or graphical methods.
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90 Days Post Implant
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Procedures utilized during LINQ ICM holding area implants.
Periodo de tiempo: 90 Days Post Implant
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Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form.
This information will be summarized using summary statistics and/or graphical methods.
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90 Days Post Implant
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Techniques utilized during LINQ ICM holding area implants.
Periodo de tiempo: 90 Days Post Implant
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Procedure duration as well as the types of personnel and resources needed for LINQ implant will be collected on the implant case report form.
This information will be summarized using summary statistics and/or graphical methods.
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90 Days Post Implant
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2015
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de noviembre de 2016
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2015
Publicado por primera vez (Estimar)
9 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
14 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201501RANA
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