AdvisaTM IPG Clinical Evaluation Study

Status Completed

Clinical Trial Summary

The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).

Clinical Trial Description

The Advisa IPG is an investigational dual chamber pacemaker that provides rate-responsive bradycardia pacing and diagnostics and atrial tachycardia detection and therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Advisa device. Data will be collected at baseline (enrollment), implant, 1-, 3- and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00839384
Study type	Interventional
Source	Medtronic Bakken Research Center
Contact
Status	Completed
Phase	N/A
Start date	February 2009
Completion date	July 2009

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