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Sponsored by: |
Medtronic Bakken Research Center |
Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00526227 |
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
Condition | Intervention |
Tachyarrhythmias |
Device: Implantable Cardioverter Defibrillator |
Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
MedlinePlus related topics: | Pacemakers and Implantable Defibrillators |
ChemIDplus related topics: | Clotrimazole Miconazole Miconazole nitrate Tioconazole |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD |
Estimated Enrollment: | 80 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
1: Experimental |
Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator will be implanted
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The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Secura Clinical Study Team | secura.brc@medtronic.com |
Germany | |||||
Hospital | Recruiting | ||||
City, Germany | |||||
Principal Investigator: Doctor Doctor |
Medtronic Bakken Research Center |
Study Chair: | Secura Clinical Study Team | Medtronic Bakken Research Center |
Study ID Numbers: | 111 |
First Received: | September 6, 2007 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00526227 |
Health Authority: | Sweden: Medical Products Agency; Finland: National Agency for Medicines; Netherlands: Dutch Health Care Inspectorate; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Greece: Ministry of Health and Welfare; Israel: Ministry of Health |
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