Status:
TERMINATED
Safety and Performance Study of the Siello S Pacing Lead
Lead Sponsor:
Biotronik, Inc.
Conditions:
Safety and Effectiveness of the Siello S Lead
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
1758 Patients enrolled
Trial Details
Trial ID
NCT01791127
Start Date
March 13 2013
End Date
April 17 2019
Last Update
June 1 2020
Active Locations (53)
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1
La Jolla, California, United States
2
La Mesa, California, United States
3
New Haven, Connecticut, United States
4
Stamford, Connecticut, United States