|Reference no. |
- Demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
- Primary Endpoint 1: Atrial Siello lead safety – 12-month adverse event-free rate (Pre-market analysis)
- Primary Endpoint 2: Ventricular Siello lead safety – 12-month adverse event-free rate (Pre-market analysis)
- Primary Endpoint 3: Siello lead effectiveness – Success rate of the implanted system including one or two Siello leads to sense and deliver pacing at 12-months post-implant (Pre-market analysis)
- Primary Endpoint 4: Siello lead safety – 5-year adverse event-free rate for primary (RV) lead position (Post-approval analysis)
- Primary Endpoint 5: Siello ventricular lead safety – Individual adverse event rates for primary (RV) lead position (Post-approval Analysis)
- 5-year adverse event-free rate for secondary (RA) lead position
- Individual adverse event rates for secondary (RA) lead position at 5 years
- Pacing threshold, sensing and impedance measurements for the atrial and ventricular Siello leads at 12-months post-implant.
- Success rate of the implanted system including one or two Siello leads to deliver long-term pacing through 5 years post-implant.
- Adverse event rates for AEs excluded from primary safety endpoint 4; through 5 years post-implant.
- Pacing threshold, sensing and impedance measurements for the Siello leads through 5 years post-implant.
- Candidate for de novo implantation of a market-released BIOTRONIK pacemaker system, including one or two Siello leads. Candidate meets recommendation for pacemaker system implant put forth by guidelines of relevant professional societies.
- Able to understand the nature of the study and provide informed consent
- Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
- Age greater than or equal to 18 years
|Main Exclusion Criteria|
- Enrolled in any other investigational clinical study
- Currently implanted with a pacemaker or ICD device
- Planned cardiac surgical procedures or interventional measures within the next 6 months
- Expected to receive a heart transplant within 1 year
- Life expectancy less than 1 year
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
- Pregnant at the time of enrollment
- A market-released BIOTRONIK pacemaker system including one or two Siello leads
- Required in-office follow-up visits 3, 6, and 12 months post-implant, with follow-ups every 6 months thereafter through 5 years of total follow-up. BIOTRONIK Home Monitoring® is allowed up to every other follow-up visit, beginning with the 18-month follow-up.
- Study initiated March 2013. Estimated study completion July 2020.