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The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-pace group | Experimental | Deactivated device group |
|
| On-Pace group | No Intervention | Ongoing device activity group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy Device | Device | Cardiac Resynchronization Therapy Device pacing activity, on or off |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical/Echocardiographic outcome | Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of participants experiencing mortality | 12 months |
| Heart failure hospitalization | Number of participants experiencing heart failure hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serkan Cay, MD | Yuksek Ihtisas Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 22, 2015 | |
| Reset | Mar 5, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 22, 2015 | Mar 5, 2015 |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058409 | Cardiac Resynchronization Therapy Devices |
| ID | Term |
|---|---|
| D010138 | Pacemaker, Artificial |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 12 months |
| Cardiac Resynchronization Therapy Device intervention | Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes. | 12 months |