Safety and Performance Study of the Siello S Pacing Lead

Safety and Effectiveness of the Siello S Lead Clinical Trial

— SIELLO  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01791127
• Other study ID #: G110221
• Status: Terminated
• Start date: March 13, 2013
• Est. completion date: April 17, 2019

Study information

• Verified date: May 2020
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1758
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Safety and Effectiveness of the Siello S Lead

Intervention

Device:
• market-released BIOTRONIK pacemaker system including one or two Siello S leads.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Siello S Lead Safety at 12 Months	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).	12 month
Primary	Ventricular Siello S Lead Safety at 12 Months	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).	12-month
Primary	Siello S Lead Effectiveness at 12 Months	Success rate of the implanted system to sense and deliver pacing at 12-months post implant.	12-months
Primary	Ventricular Siello S Lead Safety at 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).	5-Years
Primary	Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates	Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.	5-years
Secondary	Atrial Siello S Lead Safety at 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).	5-years
Secondary	Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates	Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.	5-years
Secondary	Pacing Threshold Measurements for Siello S Leads at 12 Months	Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.	12-months
Secondary	Sensing Measurements for Siello S Leads at 12 Months	Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.	12-months
Secondary	Impedance Measurements for Siello S Leads at 12 Months	Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.	12-months
Secondary	Percentage of Participants With Other Adverse Events	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.	5-years
Secondary	Siello S Lead Effectiveness at 5 Years	Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.	5-years
Secondary	Pacing Threshold Measurements for Siello S Leads Through 5 Years	Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.	5-years
Secondary	Sensing Measurements for Siello S Leads Through 5 Years	Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.	5-years
Secondary	Impedance Measurements for Siello S Leads Through 5 Years	Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.	5-years