AdvisaTM IPG Clinical Evaluation Study

Not Applicable

Completed

• Conditions: Atrial Tachyarrhythmia; Bradycardia
• Interventions: Device: Advisa IPG

• Registration Number: NCT00839384
• Lead Sponsor: Medtronic Bakken Research Center

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Patients who have an IPG indication for implantation of a dual chamber pacemaker.
• Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
• Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.

Exclusion Criteria

• Patients with a life expectancy less than the duration of the study.
• Patients with a Class III indication for permanent pacing according to ACC/AHA/NASPE 2002 guidelines.
• Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implant Advisa IPG	Advisa IPG	Advisa IPG implant

Primary Outcome Measures

Name	Time	Method
USADE at 1 month post implant	1 month	Confirm safety of the device by assessing the percentage of subjects with an unanticipated serious adverse device effect (USADE) at 1-month post-implant

Secondary Outcome Measures

Name	Time	Method
Advisa IPG system performance	1 month	System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.

Trial Locations

Locations (1)

IKEM; 🇨🇿 Prague, Czechia