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
  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
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: 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 July 29, 2014