DF4 Master Study (Safety and Efficacy Study)

Heart Failure Clinical Trial

Official title:

Master Study of the BIOTRONIK DF4 System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790841
• Other study ID #: 54
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: April 18, 2016
• Start date: February 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: AGES (Bundesamt für Sicherheit im Gesundheitswesen)Italy: Ministry of Labour, Health and Social AffairsFrance: French medicines and healthcare products safety agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Locations

Country	Name	City	State
Germany	Universitaetsmedizin Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious adverse device effect (SADE) rate related to the ICD with DF4 connection		until 3 month follow-up	Yes
Primary	SADE rate related to the Linox smart DF4 lead (ICD shock lead)		until 3 month follow-up	Yes
Primary	Shift rate of the painless shock impedance measurement		between 3 and 6 month follow-up	Yes
Primary	Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead		3 month follow-up	No
Secondary	Comparison of automatic atrial pacing threshold test vs. manual measurement		3 month follow-up	No