SIELLO

SIELLO

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

Study Objective
  • The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead
1° Endpoints
  • 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)
2° Endpoints
  • 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
Sample Size
  • 1,758 subjects
Clinical Sites
  • 60 sites in USA
Inclusion Criteria
  • 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
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
Devices
  • Any market-released BIOTRONIK pacemaker system including one or two Siello leads
Follow-Up
  • 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 Duration
  • Study start date March 2013. Estimated study completion July 2020
Reference no.
  • NCT01791127