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
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: 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 October 19, 2014