Overview

This trial is active, not recruiting.

Condition patients indicated for an icd
Treatment icd therapy - icd lead registry
Sponsor Biotronik, Inc.
Start date December 2008
End date November 2016
Trial size 2000 participants
Trial identifier NCT00836589, GALAXY

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
icd therapy - icd lead registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.

Primary Outcomes

Measure
Overall complication-free rate
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biotronik, Inc..