St.Jude Medical Cardiac Lead Assessment Study (SJM CLAS)

• The prevalence of electrical dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• The prevalence of externalized conductors in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• The prevalence of other visual lead anomalies by each subcategory (fracture, kink, subclavian crush, other irregularities) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• The annual hazard rate of lead electrical dysfunction (from enrollment) conditional on implant year in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• The annual hazard rate of new cases of externalized conductors (from enrollment), by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• The annual hazard rate of new cases of other visual lead anomalies by each subcategory (from enrollment), by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• Prevalence of "other insulation anomalies" in "returned leads" by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]

• survival from electrical malfunction in patients with leads that have externalized cables [ Time Frame: This outcome is assessed over the course of 2 years of follow-up ] [ Designated as safety issue: Yes ]
• incidence of externalized cables in the Riata®/ Riata® ST silicone endocardial leads [ Time Frame: This outcome is assessed at enrollment and over the course of 2 years of follow-up ] [ Designated as safety issue: Yes ]

• Time from enrollment to externalized conductors by year of initial implant [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Time from enrollment to other visual lead anomalies (evidenced by imaging) by year of initial implant and each subcategory. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Time from enrollment to electrical dysfunction, by year of implant [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Time from externalized conductors to electrical dysfunction, by year of initial implant. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Time from other visual lead anomalies by each lead subcategory to electrical dysfunction, by year of initial implant. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other). [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: Yes ]
• Time from externalized conductors to clinical intervention [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Time from other visual lead anomalies by each subcategory to clinical intervention. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies by each subcategory) to those without lead compromise. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
• Comparison of patients with electrical dysfunction to those without electrical dysfunction. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]

The objectives of the study are:

1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush, kink, broken filars on a shocking coil and other irregularities) by each subcategory at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
4. To determine the incidence of externalized conductors after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
5. To determine the incidence of other visual lead anomalies by each subcategory after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads.
7. To evaluate the 30-day adverse event rate associated with lead revision procedures (include lead extractions or abandonments with or without lead replacement) in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads

8. To determine the prevalence of "other insulation anomalies" in "returned leads" for Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads. "Other insulation anomalies" include any of the following:

   • Internal abrasion short under RV shock coil
   • Internal abrasion short under SVC shock coil
   • Exposed conductors defined as a breach of the outer insulation
   • Breach of the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter.

Patients that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.

Inclusion Criteria:

1. Patient has a market released SJM ICD, CRT-D or CRT-P already implanted.
2. Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1.
3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
4. Are 18 years or above

Exclusion Criteria:

1. Patient is currently pregnant.
2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study