Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG

Study Overview
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Brief Summary
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People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium). This study is now complete and the device has since been approved by the FDA.

Official Title
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Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG

Conditions
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Ventricular Arrhythmias

Intervention / Treatment
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* Device: Implantable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II) Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD) Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias) Exclusion Criteria: Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable Cardioverter Defibrillator|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy at three months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle. |  |  | 
| To evaluate how well the anti-tachycardia pacing function works. |  |  | 
| To observe the overall performance of the device system. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable Cardioverter Defibrillator, Anti-tachycardia pacing (ATP)