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Linox Smart S DX PME/Master Study

NCT ID: NCT01090401

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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ICD Indication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Linox smart S DX lead

Group Type EXPERIMENTAL

Linox smart S DX

Intervention Type DEVICE

ICD lead

Interventions

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Linox smart S DX

ICD lead

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik SE & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Charité University Hospital Benjamin Franklin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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48-1

Identifier Type: -

Identifier Source: org_study_id