Lead Registry for Optim Leads

Patients are enrolled in the registry up to 180 days post implantation of an Optim lead. Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are followed indefinitely following enrollment. Patients with other Optim leads are followed for a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is based on the established follow-up practices currently used by each of the respective registry centers. Patients are followed according to the center's standard follow-up schedule.

At each office/clinic follow-up visit standard electrical measurements are collected. During system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex® µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy or chest X-ray is performed according to the site's standard of care then copies of those should be submitted.

Inclusion criteria

• Patient has a standard indication for a CRM implantable pulse generator.
• Patient receives a market released SJM Optim lead at implant.
• Patient receives a market released CRM implantable pulse generator at implant.
• Patient is willing to provide authorization for registry participation.
• Complete device implant information, including any Optim lead related adverse event is available

Exclusion criteria

• Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months).
• Patient is < 18 years of age.
• Patient has a life expectancy of < 2 years (malignancies)