SecuraTM ICD Clinical Evaluation Study
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)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD|
- Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Describe System Performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Secura ICD implanted
Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator will be implanted
Other Name: Secura TM
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.
|Riyadh, Saudi Arabia|
|Study Chair:||Secura Clinical Study Team||Medtronic Bakken Research Center|