SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads

Biotronik

Status: Completed

Conditions: Arrhythmias, Cardiac

Treatments: Device: BPPU JT/T; Device: Pacemaker therapy; Device: SIELLO JT/T

Study type: Observational

Funder types: Industry

Identifiers

NCT01000532

47-1

Details and patient eligibility

About

This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the indications for pacemaker therapy
• Understand the nature of the procedure
• Give informed consent
• Able to complete all testing required by the clinical protocol
• Available for follow-up visits on a regular basis at the investigational site

Exclusion criteria

• Meet none of the pacemaker indications
• Meet one or more of the contraindications
• Have a life expectancy of less than six months
• Cardiac surgery in the next six months
• Enrolled in another cardiac clinical investigation
• Have other medical devices that may interact with the implanted pacemaker

Trial design

88 participants in 1 patient group

Pacemaker therapy

Treatment:

Device: Pacemaker therapy

Device: SIELLO JT/T

Device: BPPU JT/T