Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Biotronik, Inc.

ClinicalTrials.gov Identifier:

NCT00836589

First received: February 2, 2009

Last updated: May 3, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 2, 2009
Last Updated Date	May 3, 2012
Start Date ^ICMJE	December 2008
Estimated Primary Completion Date	February 2017 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00836589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Official Title ^ICMJE	GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
Brief Summary	The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.
Detailed Description	This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK ICD and consented and enrolled between 1-45 days following implant. This study is designed to be a post-implant (office-based) registry, and patients are meant to be seen according to each institution's standard of care, but not to exceed a follow-up time frame of every 6 months. At least 2000 patients will be enrolled in this registry, and each patient will be followed for five years post-implant. Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention to resolve. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. An independent Clinical Events Committee will review and adjudicate all adverse events that occur during the study according to the protocol definitions.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
Condition ^ICMJE	Patients Indicated for an ICD
Intervention ^ICMJE	Device: ICD Therapy - ICD Lead Registry Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Study Group/Cohort (s)	Data Collection Group Intervention: Device: ICD Therapy - ICD Lead Registry
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	2000
Estimated Completion Date	February 2017
Estimated Primary Completion Date	February 2017 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment Able to understand the nature of the registry and provide informed consent Available for follow-up visits on a regular basis at the investigational site Age greater than or equal to 18 years Exclusion Criteria: Enrolled in any IDE clinical study Planned cardiac surgical procedures or investigational measures within the next 6 months Expected to receive a heart transplant within 1 year Life expectancy less than 1 year Presence of another life-threatening, underlying illness separate from their cardiac disorder Pregnancy Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00836589
Other Study ID Numbers ^ICMJE	GALAXY
Has Data Monitoring Committee	No
Responsible Party	Biotronik, Inc.
Study Sponsor ^ICMJE	Biotronik, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biotronik, Inc.
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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