Trials / Completed

CompletedNCT01790841

DF4 Master Study (Safety and Efficacy Study)

Master Study of the BIOTRONIK DF4 System

Status: Completed
Phase: —
Study type: Observational
Enrollment: 240 (actual)

Sponsor: Biotronik SE & Co. KG · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.

Conditions

Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Heart Failure

Interventions

Type	Name	Description
DEVICE	Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Timeline

Start date: 2013-02-01
Primary completion: 2015-05-01
Completion: 2016-04-01
First posted: 2013-02-13
Last updated: 2016-04-19

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01790841. Inclusion in this directory is not an endorsement.