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Lumax 740 Master Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01454050
First received: October 14, 2011
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Safety and Efficacy of the Lumax 740 ICD Family

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PME/Master Study of the Lumax 740 ICD Family

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

Primary Outcome Measures:
  • Efficacy of the automatic Capture Control feature [ Time Frame: PHD, 1-, 3- and 6-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01454050     History of Changes
Other Study ID Numbers: 55
Study First Received: October 14, 2011
Last Updated: November 27, 2012
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
Italy: Ministry of Health
Slovak Republic: Ethics Committee
Slovakia: State Institute for Drug Control
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013