Safety and Performance Study of the Siello S Pacing Lead
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Biotronik, Inc.
- Enrollment
- 1,758
- Primary Endpoint
- Ventricular Siello S Lead Safety at 5 Years
Study Overview
Brief Summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Candidate for de novo implantation of a BIOTRONIK pacemaker system, including one or two Siello S 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.
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.
Outcomes
Primary Outcomes
Ventricular Siello S Lead Safety at 5 Years
Time Frame: 5-Years
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Siello S Lead Effectiveness at 12 Months
Time Frame: 12-months
Success rate of the implanted system to sense and deliver pacing at 12-months post implant.
Atrial Siello S Lead Safety at 12 Months
Time Frame: 12 month
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Ventricular Siello S Lead Safety at 12 Months
Time Frame: 12-month
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Time Frame: 5-years
Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.
Secondary Outcomes
- Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates(5-years)
- Atrial Siello S Lead Safety at 5 Years(5-years)
- Pacing Threshold Measurements for Siello S Leads Through 5 Years(5-years)
- Impedance Measurements for Siello S Leads Through 5 Years(5-years)
- Pacing Threshold Measurements for Siello S Leads at 12 Months(12-months)
- Sensing Measurements for Siello S Leads at 12 Months(12-months)
- Percentage of Participants With Other Adverse Events(5-years)
- Impedance Measurements for Siello S Leads at 12 Months(12-months)
- Siello S Lead Effectiveness at 5 Years(5-years)
- Sensing Measurements for Siello S Leads Through 5 Years(5-years)