SecuraTM ICD Clinical Evaluation Study

Study Overview
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Brief Summary
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The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)

Detailed Description
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The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics. The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers. To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), Unscheduled Follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Official Title
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Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD

Conditions
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Tachyarrhythmias

Intervention / Treatment
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* Device: Secura ICD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have an ICD indication. Patients who are geographically stable and available for follow-up at the study center for the duration of the study. Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form. Exclusion Criteria: Patients with a life expectancy less than the duration of the study. Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients. Patients with mechanical tricuspid heart valves.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secura ICD implant<br>Secura ICD device implanted | Device: Secura ICD<br>* Secura Implantable Cardioverter Defibrillator (ICD) will be implanted<br>* Other names: Secura TM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. | Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days. A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Performance Assessed by Holter Records | The first 21 digital Holter records that were successfully collected in the total of 80 implanted participants will summarize any anomalous or unintended operation and describe device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias. | 1 month | 
| Adverse Events | Number of Adverse Events reported in the implanted subjects. | 1 Month | 
| System Performance Assessed by Save to Disk Files | The Save to Disk files from 79 implanted participants collected after implant and 1 month follow up were reviewed to identify any anomolous or unintended device operation, examine device features, observe ventricular arrhythmia detection times and device classification of ventricular arrhythmias. | 1 month follow-up | 
| System Performance Assessed by Technical Observations | Reported technical observations will be reviewed to determine if there are any device performance issues. | 1 month follow-up |