Optim Lead Insulation Related Adverse Events
Conditions
Keywords
Optim, Insulation
Brief summary
This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.
Detailed description
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.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival from insulation related adverse events | 5 years |
Countries
Belgium, Germany, United States
Outcome results
None listed