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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognis 100-D, Teligen DR, VR 100 HE | Device | ICD or CRT - Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate detection of ventricular arrhythmias | Predischarge |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate shock conversion | Predischarge |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with risk of developing life threatening ventricular arrhythmias with and without heart failure
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| Name | Affiliation | Role |
|---|---|---|
| Poul Erik Bloch Thomsen, MD | KAS Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KAS Gentofte Hospital | Hellerup | 2900 | Denmark | |||
| Barzilay Medical Center |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Ashkelon |
| 78306 |
| Israel |
| Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |