Active, not recruitingInterventionalNot ApplicableUpdated Nov 18, 2025
Safety and Performance Study of the Siello S Pacing Lead | NCT01791127 | Trialant
TerminatedObservationalUpdated Jun 1, 2020
Safety and Performance Study of the Siello S Pacing Lead
ClinicalTrials.gov ID
NCT01791127
Lead Sponsor
Biotronik, Inc.INDUSTRY
Overall Status
Terminated
Study Type
Observational
Enrollment
1,758Actual
Last Update Posted
Jun 1, 2020Actual
Start Date
Mar 13, 2013Actual
Primary Completion Date
Apr 17, 2019Actual
Completion Date
Apr 17, 2019Actual
Brief Summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Safety and Effectiveness of the Siello S Lead
market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.