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

Biotronik

Status

Terminated

Conditions

Safety and Effectiveness of the Siello S Lead

Treatments

Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

Study type

Observational

Funder types

Industry

Identifiers

G110221

Details and patient eligibility

About

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

Enrollment

1,758 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.