DF4 Master Study (Safety and Efficacy Study)

• Sponsor: Biotronik SE & Co. KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01790841
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Duration (Months): 37.9
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Heart Failure	Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Master Study of the BIOTRONIK DF4 System
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
ICD system with DF4 connection Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego	Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
ICD system with DF-1 connection Ilesto/Iforia ICD with DF-1 connection	Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego

Outcome Measures

Primary Outcome Measures

1. Serious adverse device effect (SADE) rate related to the ICD with DF4 connection [until 3 month follow-up]

2. SADE rate related to the Linox smart DF4 lead (ICD shock lead) [until 3 month follow-up]

3. Shift rate of the painless shock impedance measurement [between 3 and 6 month follow-up]

4. Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead [3 month follow-up]

Secondary Outcome Measures

1. Comparison of automatic atrial pacing threshold test vs. manual measurement [3 month follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitaetsmedizin Greifswald	Greifswald		Germany

Sponsors and Collaborators

• Biotronik SE & Co. KG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik SE & Co. KG
• ClinicalTrials.gov Identifier: NCT01790841
• Other Study ID Numbers: 54
• First Posted: Feb 13, 2013
• Last Update Posted: Apr 19, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac; Ventricular Fibrillation; Death

Study Results

No Results Posted as of Apr 19, 2016