Linox Smart S DX PME/Master Study

November 15, 2011 updated by: Biotronik SE & Co. KG

PME/Master Study of the Linoxsmart S DX ICD Leads

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charite University Hospital Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Linox smart S DX lead
Device: Linox smart S DX
ICD lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of atrial adequate sensing
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Linox smart S DX related complication-free rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (ESTIMATE)

March 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 48-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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