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

Biotronik

Status: Completed

Conditions: Patients Indicated for an ICD

Treatments: Device: ICD Therapy - ICD Lead Registry

Study type: Observational

Funder types: Industry

Identifiers

NCT00836589

GALAXY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,997 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,997 participants in 1 patient group

Data Collection Group

Treatment:

Device: ICD Therapy - ICD Lead Registry