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: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Patients Indicated for an ICD
Device: ICD Therapy - ICD Lead Registry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • Overall complication-free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: December 2008
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Data Collection Group Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.

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.

  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 will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836589

  Show 86 Study Locations
Sponsors and Collaborators
Biotronik, Inc.
  More Information

No publications provided

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00836589     History of Changes
Other Study ID Numbers: GALAXY
Study First Received: February 2, 2009
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:
Long-term safety and reliability of ICD leads

ClinicalTrials.gov processed this record on April 15, 2014