Safety and Performance Study of the Siello S Pacing Lead

Terminated

• Conditions: Safety and Effectiveness of the Siello S Lead
• Interventions: Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

• Registration Number: NCT01791127
• Lead Sponsor: Biotronik, Inc.

Brief Summary

The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Study Start: 2013-03-13
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Results First Submitted: 2020-04-08
• Results First Submitted QC: 2020-04-08
• Results First Posted: 2020-04-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1758

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pacemaker Therapy	market-released BIOTRONIK pacemaker system including one or two Siello S leads.	Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.

Primary Outcome Measures

Name	Time	Method
Ventricular Siello S Lead Safety at 5 Years	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	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	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	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	5-years	Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.

Secondary Outcome Measures

Name	Time	Method
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates	5-years	Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.
Atrial Siello S Lead Safety at 5 Years	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 atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Pacing Threshold Measurements for Siello S Leads Through 5 Years	5-years	Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.
Impedance Measurements for Siello S Leads Through 5 Years	5-years	Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Pacing Threshold Measurements for Siello S Leads at 12 Months	12-months	Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Sensing Measurements for Siello S Leads at 12 Months	12-months	Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Percentage of Participants With Other Adverse Events	5-years	The overall percentage of subjects with reportable adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Adverse events were considered reportable if the event was related to the implant procedure, implanted pulse generator, or implanted leads.
Impedance Measurements for Siello S Leads at 12 Months	12-months	Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Siello S Lead Effectiveness at 5 Years	5-years	Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.
Sensing Measurements for Siello S Leads Through 5 Years	5-years	Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.