Safety and Performance Study of the Siello S Pacing Lead
NCT ID: NCT01791127
Last Updated: 2020-06-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
1758 participants
OBSERVATIONAL
2013-03-13
2019-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
NCT01000532
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
NCT00943046
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
NCT02290028
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
NCT06540079
Specialized Pacing for Patients With Congenital Heart Disease
NCT03361189
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pacemaker Therapy
Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
La Jolla, California, United States
La Mesa, California, United States
New Haven, Connecticut, United States
Stamford, Connecticut, United States
Plantation, Florida, United States
St. Petersburg, Florida, United States
Cumming, Georgia, United States
Chicago, Illinois, United States
Jerseyville, Illinois, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
Iowa City, Iowa, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
Warren, Michigan, United States
Ypsilanti, Michigan, United States
Tupelo, Mississippi, United States
Cape Girardeau, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Bridgewater, New Jersey, United States
Haddon Heights, New Jersey, United States
Flushing, New York, United States
Concord, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Steubenville, Ohio, United States
Toledo, Ohio, United States
Philadelphia, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
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
Alice, Texas, United States
Bedford, Texas, United States
Orange, Texas, United States
San Antonio, Texas, United States
Victoria, Texas, United States
Salt Lake City, Utah, United States
Fredericksburg, Virginia, United States
Richmond, Virginia, United States
Milwaukee, Wisconsin, United States
Cheyenne, Wyoming, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G110221
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.