The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial (HALT)
14 de janeiro de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 estudo
Observacional
Inscrição (Real)
20
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cost-effectiveness for LINQ ICM holding area implants.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2015
Conclusão Primária (Real)
1 de junho de 2016
Conclusão do estudo (Real)
1 de novembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
30 de junho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de julho de 2015
Primeira postagem (Estimativa)
9 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de janeiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de janeiro de 2022
Última verificação
1 de janeiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201501RANA
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