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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Pacemaker Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Siello pacemaker lead

Patients with Siello Pacemaker lead

Group Type EXPERIMENTAL

Pacemaker therapy

Intervention Type DEVICE

Implantation of the SIELLO pacemaker leads

Interventions

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Pacemaker therapy

Implantation of the SIELLO pacemaker leads

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No