Protego DF4 Post Approval Registry

Study Overview
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Brief Summary
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The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

Official Title
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Protego DF4 Post Approval Registry

Conditions
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Implantable Defibrillator User

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies 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 for the expected 5 years of follow-up Age greater than or equal to 18 years Exclusion Criteria: Enrolled in any investigational cardiac device trial Planned cardiac surgical procedures or interventional measures within the next 6 months Expected to receive heart transplantation or ventricular assist device within 1 year Life expectancy of less than 1 year Presence of another life-threatening, underlying illness separate from their cardiac disorder Patients reporting pregnancy at the time of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With No Protego DF4 Lead Adverse Event | Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate. | Up to 4.5 years | 
| Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'. | Up to 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protego DF4 Lead Pacing Threshold Measurement | Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years | 
| Protego DF4 Lead Shock Impedance | Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years | 
| Percentage of Subjects With no Adverse Events Excluded From Primary Objectives | The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). | Up to 4.5 years | 
| Protego DF4 Lead Sensing | Sensing measurements for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years | 
| Protego DF4 Lead Pacing Impedance | Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years |