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

B

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

NCT01791127
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.

Trial design

1,758 participants in 1 patient group

Pacemaker Therapy
Description:
Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Treatment:
Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

Trial documents
1

Trial contacts and locations

53

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Data sourced from clinicaltrials.gov

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