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Lumax 740 Master Study (Lumax 740)

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ClinicalTrials.gov Identifier: NCT01454050
Recruitment Status : Completed
First Posted : October 18, 2011
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.

Condition or disease
Safety and Efficacy of the Lumax 740 ICD Family

Study Type : Observational
Actual Enrollment : 189 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PME/Master Study of the Lumax 740 ICD Family
Study Start Date : November 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012



Primary Outcome Measures :
  1. Efficacy of the automatic Capture Control feature [ Time Frame: PHD, 1-, 3- and 6-month follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard ICD indication who are referred to the hospital.
Criteria

Inclusion Criteria:

  • Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.

    • Legal capacity and ability to consent
    • Signed patient informed consent

In addition for HF-T devices:

  • Bipolar LV-lead with a min. distance of 15 mm between tip and ring
  • True bipolar RV lead

Exclusion Criteria:

  • Standard contraindication for single, dual, or triple chamber ICD.

    • Age < 18 years
    • Pregnant or breast-feeding woman
    • Cardiac surgery planned within the next 6 months
    • Life expectancy of less than 6 months
    • Participating in any other clinical study of an investigational cardiac drug or device

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): NCT01454050


Locations
Germany
Medical School Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Gunnar Klein, Prof. Dr. Herz im Zentrum Hannover, Germany

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01454050     History of Changes
Other Study ID Numbers: 55
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Biotronik SE & Co. KG:
ICD therapy
RV/LV Capture Control
Safety and Efficacy