Linox Smart S DX PME/Master Study

Phase 4

Completed

• Conditions: ICD Indication
• Interventions: Device: Linox smart S DX

• Registration Number: NCT01090401
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-22
• Primary Completion: 2010-12
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patients with standard ICD indication
• Be available for follow-up visits on a regular basis at an approved investigational center

Exclusion Criteria

• Patients with standard ICD contra-indication
• Patients with permanent atrial fibrillation
• Have a life expectancy of less than six months
• Are expecting to receive cardiac surgery within 6 months after enrollment
• Age < 18 years
• Not enrolled in another cardiac clinical investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Linox smart S DX lead	Linox smart S DX	-

Primary Outcome Measures

Name	Time	Method
Rate of atrial adequate sensing	6 months

Secondary Outcome Measures

Name	Time	Method
Linox smart S DX related complication-free rate	6 months

Trial Locations

Locations (1)

Charité University Hospital Benjamin Franklin; 🇩🇪 Berlin, Germany