Lumax DX / Linox DX Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01486836
First received: November 15, 2011
Last updated: September 11, 2013
Last verified: September 2013
  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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of appropriate atrial sensing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate of successfully terminated tachyarrhythmia episodes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Serious adverse device effect rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486836

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01486836     History of Changes
Other Study ID Numbers: 58
Study First Received: November 15, 2011
Last Updated: September 11, 2013
Health Authority: Germany: Ethics Commission
Hungary: Ethics Commission

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014