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Linox Smart S DX PME/Master Study

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ClinicalTrials.gov Identifier: NCT01090401
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
ICD Indication Device: Linox smart S DX Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PME/Master Study of the Linoxsmart S DX ICD Leads
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Patients with Linox smart S DX lead Device: Linox smart S DX
ICD lead




Primary Outcome Measures :
  1. Rate of atrial adequate sensing [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Linox smart S DX related complication-free rate [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090401


Locations
Germany
Charité University Hospital Benjamin Franklin
Berlin, Germany, 12200
Sponsors and Collaborators
Biotronik SE & Co. KG

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01090401     History of Changes
Other Study ID Numbers: 48-1
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011