SIELLO Clinical Trial

Safety and Performance Study of the Siello S Pacing Lead

Study Design

Prospective, non-randomized, multi-center combined pre-market study and post-approval registry
The purpose of this observational study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead
1,758 subjects enrolled at 60 US sites - This study is ongoing

The objective of the SIELLO study is to 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 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

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

Any 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