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

Completed

Conditions: Patients Indicated for an ICD

Interventions: Device: ICD Therapy - ICD Lead Registry

Registration Number: NCT00836589

Lead Sponsor: Biotronik, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1997

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Data Collection Group	ICD Therapy - ICD Lead Registry	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type	5 years	Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead	5 years	The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).

Secondary Outcome Measures

Name	Time	Method
Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.	5 years	The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.
Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.	5 years	The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.	5 years
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	5 years	The mean sensing measurement is calculated as a mean across all study visits.
Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	5 years	Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold is calculated as a mean across all study visits.
Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.	5 years	Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold of each Linox Lead System model was calculated as a mean across all study visits.
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.	5 years
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	5 years	The mean pacing impedance measurement is calculated as a mean across all study visits.