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This study is intended to look at the effect of the SJM vibrating Patient Notifierâ„¢ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Patient Notifier turned OFF |
|
| Treatment group | Experimental | Patient Notifier turned ON |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD implant + Patient Notifier turned OFF | Device | ICD implant, plus standard care, i.e. Patient Notifier turned off |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10) | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifierâ„¢ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality | 1year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Firat Duru, Prof. | Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversitätsSpital Zürich | Zurich | CH-8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20207746 | Derived | Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| ICD Implant + Patient Notifier turned ON | Procedure | ICD implant. The Patient Notifierâ„¢ feature will be turned ON. |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |