Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotronik, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Safety and Performance Study of the Siello S Pacing Lead
