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The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D | Device |
| Measure | Description | Time Frame |
|---|---|---|
| System Complication-Free Rate at 6 months | ||
| Effectiveness of LV Only/LV Offset at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| LVESD at 6 months | ||
| Six-minute walk at 6 months | ||
| NYHA at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Sperzel, MD | Kerckhoff Klinik Bad Nauheim (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhof Klinik | Bad Nauheim | 61231 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
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| QOL at 6 months |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |