NCT00839384

AdvisaTM IPG Clinical Evaluation Study

Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Bradycardia
• Atrial Tachyarrhythmia

Interventions

Type	Name	Description
DEVICE	Advisa IPG	Implantable Pulse Generator will be implanted

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-02-09
• Last updated: 2025-07-03

Locations

1 site across 1 country: Czechia