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OpenTrials
Completed

NCT Number: NCT01090401

Linox Smart S DX PME/Master Study

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

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Key information

Conditions

ICD Indication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité University Hospital Benjamin Franklin

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linox smart S DX

Device

ICD lead

Primary outcomes

  1. Rate of atrial adequate sensing

    Time frame: 6 months

Secondary outcomes

  1. Linox smart S DX related complication-free rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

PME/Master Study of the Linoxsmart S DX ICD Leads

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 22, 2010
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.