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Sponsors and Collaborators: |
Medtronic Cardiac Rhythm Disease Management Medtronic |
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Information provided by: | Medtronic Cardiac Rhythm Disease Management |
ClinicalTrials.gov Identifier: | NCT00279279 |
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.
Condition | Intervention |
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Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD) Fibrillation, Ventricular Syncope |
Device: Implanted Device |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | PREPARE - Primary Prevention Parameters Evaluation |
Estimated Enrollment: | 700 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | May 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Principal Investigator: | Bruce Wilkoff, M.D | The Cleveland Clinic |
Study ID Numbers: | 223 |
Study First Received: | January 17, 2006 |
Last Updated: | October 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00279279 |
Health Authority: | United States: Institutional Review Board |
Implantable cardioverter defibrillator (ICD) Sudden Cardiac Death Primary Prevention |
Death Heart Diseases Tachycardia Paroxysmal ventricular fibrillation Death, Sudden, Cardiac |
Tachycardia, Ventricular Syncope Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |