DF4 Master Study (Safety and Efficacy Study)

Completed

• Conditions: Sudden Cardiac Death; Ventricular Fibrillation; Heart Failure; Ventricular Tachycardia
• Interventions: Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

• Registration Number: NCT01790841
• Lead Sponsor: Biotronik SE & Co. KG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2015-05
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patient has provided written informed consent.
• Patient has standard ICD/CRT-D indication.
• Patient accepts Home Monitoring concept.
• Patient is able to attend the planned hospital follow-up visits.
• Patient has legal capacity and ability to consent.

Exclusion Criteria

• Patient has a standard contra-indication for ICD/CRT-D therapy.
• Age < 18 years
• Patient is pregnant or breastfeeding.
• Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months.
• Life expectancy of less than 12 months.
• Participating in any other clinical study of an investigational cardiac drug or device.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICD system with DF-1 connection	Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego	Ilesto/Iforia ICD with DF-1 connection
ICD system with DF4 connection	Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego	Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego

Primary Outcome Measures

Name	Time	Method
Serious adverse device effect (SADE) rate related to the ICD with DF4 connection	until 3 month follow-up
SADE rate related to the Linox smart DF4 lead (ICD shock lead)	until 3 month follow-up
Shift rate of the painless shock impedance measurement	between 3 and 6 month follow-up
Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead	3 month follow-up

Secondary Outcome Measures

Name	Time	Method
Comparison of automatic atrial pacing threshold test vs. manual measurement	3 month follow-up

Trial Locations

Locations (1)

Universitaetsmedizin Greifswald; 🇩🇪 Greifswald, Germany