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| Name | Class |
|---|---|
| LivaNova | INDUSTRY |
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The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT Therapy | Experimental | All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paradym CRT + Physiological Diagnosis (PhD) | Device | All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee). | Thirteen months | |
| Mean number of false positives per patient per year. | Thirteen Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Vista Hospital | Mesa | Arizona | 85209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20947571 | Background | Auricchio A, Brugada J, Ellenbogen KA, Gold MR, Leyva F; CLEPSYDRA investigators. Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study. Eur J Heart Fail. 2010 Dec;12(12):1363-71. doi: 10.1093/eurjhf/hfq170. Epub 2010 Oct 14. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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