Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

Biotronik

Status: Completed

Conditions: Cardiac Pacemaker Syndrome

Treatments: Device: Pacemaker therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943046

43-1

Details and patient eligibility

About

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Full description

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Enrollment: 164 patients

Sex: All

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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

164 participants in 1 patient group

Siello pacemaker lead

Experimental group

Description:

Patients with Siello Pacemaker lead

Treatment:

Device: Pacemaker therapy