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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implanted Device | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that patients programmed using a prescribed set of parameters have a lower rate of cardiac syncope, symptoms of fast heart rate, VT/VF events and cardioversion or defibrillation shocks compared to patients programmed per physician discretion |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the percentage of inappropriate VT/VF detections | ||
| characterize the true incidence of VT/VF detections | ||
| therapy efficacy |
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Inclusion Criteria:
Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time.
Exclusion Criteria:
Patient has history of spontaneous sustained symptomatic ventricular arrhythmias.
If patient has had an electrophysiology test in the past, and has sustained inducible VT <180 bpm.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Wilkoff, M.D | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21605131 | Derived | van Gelder IC, Phan HM, Wilkoff BL, Brown ML, Rogers T, Peterson BJ, Birgersdotter-Green UM. Prognostic significance of atrial arrhythmias in a primary prevention ICD population. Pacing Clin Electrophysiol. 2011 Sep;34(9):1070-9. doi: 10.1111/j.1540-8159.2011.03124.x. Epub 2011 May 23. | |
| 18687248 | Derived | Wilkoff BL, Williamson BD, Stern RS, Moore SL, Lu F, Lee SW, Birgersdotter-Green UM, Wathen MS, Van Gelder IC, Heubner BM, Brown ML, Holloman KK; PREPARE Study Investigators. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol. 2008 Aug 12;52(7):541-50. doi: 10.1016/j.jacc.2008.05.011. |
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| time to first inappropriate VT/VF detection |
| incidence of untreated but monitored VT |
| programming changes |
| deaths and cardiovascular adverse event |
| Mesa |
| Arizona |
| United States |
| Phoenix | Arizona | United States |
| San Diego | California | United States |
| San Pablo | California | United States |
| Newark | Delaware | United States |
| Fort Lauderdale | Florida | United States |
| Jacksonville | Florida | United States |
| Merrit Island | Florida | United States |
| Columbus | Georgia | United States |
| Maywood | Illinois | United States |
| Rockford | Illinois | United States |
| Topeka | Kansas | United States |
| Portland | Maine | United States |
| Silver Spring | Maryland | United States |
| Takoma Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Royal Oak | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Paterson | New Jersey | United States |
| Buffalo | New York | United States |
| New York | New York | United States |
| Columbus | Ohio | United States |
| Elyria | Ohio | United States |
| Bethlehem | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Kirkland | Washington | United States |
| Morgantown | West Virginia | United States |
| San Juan | Puerto Rico |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D013575 | Syncope |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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