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Lumax DX / Linox DX Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486836
First Posted: December 7, 2011
Last Update Posted: September 12, 2013
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 investigate the safety and efficacy of the Lumax DX / Linox DX system.

No hypothesis has been defined.


Condition
Cardiac Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)

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

Primary Outcome Measures:
  • Rate of appropriate atrial sensing [ Time Frame: 3 months ]
  • Rate of successfully terminated tachyarrhythmia episodes [ Time Frame: 3 months ]
  • Serious adverse device effect rate [ Time Frame: 3 months ]

Estimated Enrollment: 38
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICD therapy

  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
Sampling Method:   Probability Sample
Study Population
Patients with standard ICD indication who are referred to the hospital.
Criteria

Inclusion Criteria:

  • Patient meets the indication for ICD therapy
  • LVEF ≥ 30%
  • Patient's compliance with protocol
  • Signed patient informed consent form

Exclusion Criteria:

  • Patient meets one contraindication for ICD therapy
  • Permanent atrial tachyarrhythmia
  • Age < 18 years
  • Cardiac surgery planned within the next 6 months
  • Life expectancy of less than 6 months
  • Limited contractual capability
  • Participating in another clinical study of an investigational cardiac drug or device
  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): NCT01486836


Locations
Germany
Charité Uniklinikum Benjamin Franklin
Berlin, N.a., Germany, 12200
Sponsors and Collaborators
Biotronik SE & Co. KG
  More Information

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01486836     History of Changes
Other Study ID Numbers: 58
First Submitted: November 15, 2011
First Posted: December 7, 2011
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Biotronik SE & Co. KG:
Cardiac disease (ICD indication)

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases