The Holding Area LINQ (Reveal LINQ Insertable Cardiac Monitor) Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial (HALT)
14 janvier 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
20
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Florida
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Fort Lauderdale, Florida, États-Unis, 33308
- Jim Moran Heart and Vascular Research Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients 18 and older indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cost-effectiveness for LINQ ICM holding area implants.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2015
Achèvement primaire (Réel)
1 juin 2016
Achèvement de l'étude (Réel)
1 novembre 2016
Dates d'inscription aux études
Première soumission
30 juin 2015
Première soumission répondant aux critères de contrôle qualité
8 juillet 2015
Première publication (Estimation)
9 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 janvier 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 janvier 2022
Dernière vérification
1 janvier 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201501RANA
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