NCT01963286

Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 735 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.

Detailed description

With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.

Conditions

• Tachycardia

Interventions

Type	Name	Description
DEVICE	ICD with enhanced SVT discriminators	ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-10-16
• Last updated: 2019-02-04

Locations

23 sites across 2 countries: Estonia, Germany