Study Stopped
On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology.
Safety and Performance Study of the Siello S Pacing Lead
SIELLO
1 other identifier
observational
1,758
1 country
53
Brief Summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedStudy Start
First participant enrolled
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2019
CompletedResults Posted
Study results publicly available
April 22, 2020
CompletedJune 1, 2020
May 1, 2020
6.1 years
February 12, 2013
April 8, 2020
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (10)
Atrial Siello S Lead Safety at 5 Years
5-years
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
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
Impedance Measurements for Siello S Leads at 12 Months
12-months
- +5 more secondary outcomes
Study Arms (1)
Pacemaker Therapy
Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Interventions
Eligibility Criteria
The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (53)
Unknown Facility
La Jolla, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Stamford, Connecticut, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Cumming, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Jerseyville, Illinois, United States
Unknown Facility
Park Ridge, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Valparaiso, Indiana, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Grand Blanc, Michigan, United States
Unknown Facility
Warren, Michigan, United States
Unknown Facility
Ypsilanti, Michigan, United States
Unknown Facility
Tupelo, Mississippi, United States
Unknown Facility
Cape Girardeau, Missouri, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Bridgewater, New Jersey, United States
Unknown Facility
Haddon Heights, New Jersey, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
Concord, North Carolina, United States
Unknown Facility
Fargo, North Dakota, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Middletown, Ohio, United States
Unknown Facility
Steubenville, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Wynnewood, Pennsylvania, United States
Unknown Facility
Anderson, South Carolina, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Lancaster, South Carolina, United States
Unknown Facility
Rock Hill, South Carolina, United States
Unknown Facility
West Columbia, South Carolina, United States
Unknown Facility
Alice, Texas, United States
Unknown Facility
Bedford, Texas, United States
Unknown Facility
Orange, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Victoria, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Fredericksburg, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Cheyenne, Wyoming, United States
Related Publications (1)
Mullane S, Hicks JB, Sharmin K, Harrell C, Rock A, Miller C. Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data. Pragmat Obs Res. 2024 Dec 19;15:233-241. doi: 10.2147/POR.S499248. eCollection 2024.
PMID: 39720009DERIVED
Results Point of Contact
- Title
- Clinical Studies Engineer Manager
- Organization
- BIOTRONIK, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2013
First Posted
February 13, 2013
Study Start
March 13, 2013
Primary Completion
April 17, 2019
Study Completion
April 17, 2019
Last Updated
June 1, 2020
Results First Posted
April 22, 2020
Record last verified: 2020-05