Tachyarrhythmias Clinical Trial
Official title:
Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
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)
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00982397 -
Safety and Clinical Performance of the Protecta ICD and CRT-D
|
N/A | |
| Completed |
NCT00746564 -
Study of New Implantable Loop Recorder
|
N/A | |
| Completed |
NCT00526162 -
ConsultaTM CRT-D Clinical Evaluation Study
|
N/A | |
| Completed |
NCT00870324 -
OptiSense™ Performance in Detecting Atrial Episodes
|
||
| Completed |
NCT00940888 -
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
|