N/A
Completed N=1,997
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Patients Indicated for an ICD
Source: ClinicalTrials.gov NCT00836589 ↗
Enrolled (actual)
1,997
Serious AEs
10.8%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead — 90.9 percentage of subjects — p=0.0020
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead |
90.9 | 0.0020 sig |
| PRIMARY Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type |
25; 20; 17; 6; 2; 1 | — |
| SECONDARY 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. |
42; 6; 58; 22 | — |
| SECONDARY Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant. |
39 | — |
| SECONDARY Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. |
0.64 | — |
| SECONDARY Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. |
12.77 | — |
| SECONDARY Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. |
552.9 | — |
| SECONDARY Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. |
0.62; 0.64; 0.50; 0.76; 0.59; 0.66 | — |
| SECONDARY Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. |
13.66; 12.71; 5.63; 10.96; 13.12; 12.25 | — |
| SECONDARY Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. |
550.9; 541.8; 812.0; 784.8; 541.5; 546.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00836589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.