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Protego DF4 Post Approval Registry

Primary Endpoint 2: Protego DF4 Lead Safety Individual 5-Year Adverse Event-Free Rates Each of the individual types of adverse events contributing to primary endpoint 1 will be evaluated separately in the following superiority hypothesis. Ho: The individual adverse event rate (AEIndividual) for a given type of AE for the Protego DF4 lead at 5 years post-implant is greater than or equal to 1% AEIndividual greater than or equal to 1% Ha: The individual adverse event rate (AEIndividual) for a given type of AE for the Protego DF4 lead at 5 years post-implant is less than 1% AEIndividual less than 1% If the two-sided, 95% upper confidence bound is no more than 1% for individual adverse events, then the null hypothesis will be rejected for that AE type. Secondary Endpoints There are no formal tests of hypotheses associated with secondary endpoints 1-3. 1. Pacing threshold, sensing and impedance measurements for the Protego DF4 lead through 5 years post-implant. 2. Shock impedance for the Protego lead through 5 years post-implant. 3. Adverse event rates for protocol defined, CEC adjudicated AEs excluded from primary safety endpoints 1 and 2, through 5 years post-implant.

Primary Endpoint 2: Protego DF4 Lead Safety Individual 5-Year Adverse Event-Free Rates Each of the individual types of adverse events contributing to primary endpoint 1 will be evaluated separately in the following superiority hypothesis. Ho: The individual adverse event rate (AEIndividual) for a given type of AE for the Protego DF4 lead at 5 years post-implant is greater than or equal to 1% AEIndividual greater than or equal to 1% Ha: The individual adverse event rate (AEIndividual) for a given type of AE for the Protego DF4 lead at 5 years post-implant is less than 1% AEIndividual less than 1% If the two-sided, 95% upper confidence bound is no more than 1% for individual adverse events, then the null hypothesis will be rejected for that AE type. Secondary Endpoints There are no formal tests of hypotheses associated with secondary endpoints 1-3. 1. Pacing threshold, sensing and impedance measurements for the Protego DF4 lead through 5 years post-implant. 2. Shock impedance for the Protego lead through 5 years post-implant. 3. Adverse event rates for protocol defined, CEC adjudicated AEs excluded from primary safety endpoints 1 and 2, through 5 years post-implant.