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Linox Smart S DX PME/Master Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090401
First Posted: March 22, 2010
Last Update Posted: November 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
  Purpose
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.

Condition Intervention Phase
ICD Indication Device: Linox smart S DX Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PME/Master Study of the Linoxsmart S DX ICD Leads

Further study details as provided by Biotronik SE & Co. KG:

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

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

Enrollment: 116
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with Linox smart S DX lead Device: Linox smart S DX
ICD lead

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01090401     History of Changes
Other Study ID Numbers: 48-1
First Submitted: March 18, 2010
First Posted: March 22, 2010
Last Update Posted: November 16, 2011
Last Verified: November 2011