Safety and Performance Study of the Siello S Pacing Lead (SIELLO)

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 1758

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States
    • La Mesa, California, United States
  • Connecticut
    • New Haven, Connecticut, United States
    • Stamford, Connecticut, United States
  • Florida
    • Plantation, Florida, United States
    • Saint Petersburg, Florida, United States
  • Georgia
    • Cumming, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Jerseyville, Illinois, United States
    • Park Ridge, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
    • Valparaiso, Indiana, United States
  • Iowa
    • Iowa City, Iowa, United States
  • Massachusetts
    • Worcester, Massachusetts, United States
  • Michigan
    • Ann Arbor, Michigan, United States
    • Detroit, Michigan, United States
    • Grand Blanc, Michigan, United States
    • Warren, Michigan, United States
    • Ypsilanti, Michigan, United States
  • Mississippi
    • Tupelo, Mississippi, United States
  • Missouri
    • Cape Girardeau, Missouri, United States
    • Kansas City, Missouri, United States
    • Saint Louis, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Jersey
    • Bridgewater, New Jersey, United States
    • Haddon Heights, New Jersey, United States
  • New York
    • Flushing, New York, United States
  • North Carolina
    • Concord, North Carolina, United States
  • North Dakota
    • Fargo, North Dakota, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Columbus, Ohio, United States
    • Middletown, Ohio, United States
    • Steubenville, Ohio, United States
    • Toledo, Ohio, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
    • Wynnewood, Pennsylvania, United States
  • South Carolina
    • Anderson, South Carolina, United States
    • Charleston, South Carolina, United States
    • Columbia, South Carolina, United States
    • Greenville, South Carolina, United States
    • Lancaster, South Carolina, United States
    • Rock Hill, South Carolina, United States
    • West Columbia, South Carolina, United States
  • Texas
    • Alice, Texas, United States
    • Bedford, Texas, United States
    • Orange, Texas, United States
    • San Antonio, Texas, United States
    • Victoria, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Fredericksburg, Virginia, United States
    • Richmond, Virginia, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States
  • Wyoming
    • Cheyenne, Wyoming, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pacemaker Therapy; Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.	Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2013
• Primary Completion (Actual): April 17, 2019
• Study Completion (Actual): April 17, 2019

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: G110221