Linox Smart S DX PME/Master Study

Phase 4CompletedNCT01090401

Biotronik SE & Co. KG116 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

ICD Indication

Interventions

Linox smart S DXDEVICE

ICD lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité University Hospital Benjamin Franklin

Berlin, Germany

Outcomes

Primary Outcomes

Rate of atrial adequate sensing

Time frame: 6 months

Secondary Outcomes

Linox smart S DX related complication-free rate

Time frame: 6 months

Data from ClinicalTrials.gov

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