NCT00526227

SecuraTM ICD Clinical Evaluation Study

Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Tachyarrhythmias

Interventions

Type	Name	Description
DEVICE	Secura ICD	Secura Implantable Cardioverter Defibrillator (ICD) will be implanted

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2008-10-01
• First posted: 2007-09-10
• Last updated: 2025-07-02
• Results posted: 2009-06-10

Locations

13 sites across 7 countries: Austria, Finland, Germany, Greece, Netherlands, Saudi Arabia, Sweden