This trial is active, not recruiting.

Condition optim lead insulation related adverse events
Sponsor St. Jude Medical
Start date August 2006
End date December 2017
Trial size 14124 participants
Trial identifier NCT01722188, CD0196


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Survival from insulation related adverse events
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Optim Lead Insulation Material Registry
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by St. Jude Medical.