The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
Study Type
OBSERVATIONAL
Enrollment
1,694
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.
Time frame: 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'.
Time frame: Up to 4.5 years
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.
Time frame: Up to 4.5 years
Protego DF4 Lead Shock Impedance
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Time frame: 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).
Time frame: Up to 4.5 years
Protego DF4 Lead Sensing
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Time frame: Up to 4.5 years
Protego DF4 Lead Pacing Impedance
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Gadsden, Alabama, United States
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Avondale, Arizona, United States
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Glendale, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Escondido, California, United States
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Fountain Valley, California, United States
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Hawthorne, California, United States
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Los Angeles, California, United States
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Santa Barbara, California, United States
...and 58 more locations
Time frame: Up to 4.5 years