Linox Smart S DX PME/Master Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01090401
First received: March 18, 2010
Last updated: November 15, 2011
Last verified: November 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090401

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01090401     History of Changes
Other Study ID Numbers: 48-1
Study First Received: March 18, 2010
Last Updated: November 15, 2011
Health Authority: Germany: Ethikkommission der Charité -Universitätsmedizin, Berlin

ClinicalTrials.gov processed this record on April 14, 2014