Trial results from the Optisure Lead Post Approval Study, investigating the chronic performance of St. Jude Medical Optisure HV leads in patients with Heart Failure and Ventricular Tachycardia, were posted on 2025-07-30. The study, which enrolled 1735 participants, reported a 96.3% complication-free survival rate at 5 years for complications related to the Optisure RV leads.
Background
Heart failure is a chronic, progressive condition affecting the heart's ability to pump blood effectively. Ventricular tachycardia is a type of rapid heart rhythm that originates in the lower chambers of the heart. Both conditions can be life-threatening and often require implantable devices, such as pacemakers or implantable cardioverter-defibrillators (ICDs), which rely on leads to deliver therapy. The long-term performance and safety of these leads are paramount for patient well-being and device efficacy. Post-market surveillance studies, like this one, are conducted to monitor the real-world performance of medical devices after their initial approval.
Trial design
This post-approval study, titled "Optisure Lead Post Approval Study," was designed to characterize the chronic performance of the St. Jude Medical Optisure family of HV leads. The study enrolled 1735 participants diagnosed with Heart Failure and Tachycardia, Ventricular. The primary objective was to assess the long-term safety and performance of the Optisure RV leads.
Key results
- Complication Free Survival Rate at 5 Years for Complications Related to the Optisure RV Leads:
- For the St. Jude Medical Optisure Lead group, the rate was 96.3% pts free from RV related complications.
What this means
The results from this post-approval study provide important data regarding the long-term performance of the St. Jude Medical Optisure RV leads in patients with heart failure and ventricular tachycardia. A 96.3% complication-free survival rate at 5 years for lead-related complications suggests a favorable safety profile for these leads over an extended period. This information is valuable for clinicians in assessing the long-term reliability of the Optisure lead family when making decisions about device implantation for patients requiring high-voltage lead therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02235545, titled "Optisure Lead Post Approval Study," were posted on 2025-07-30 on clinicaltrials.gov.