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
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, see Learn About Clinical Studies.

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 August 01, 2014