AdvisaTM IPG Clinical Evaluation Study

Medtronic Cardiac Rhythm and Heart Failure79 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bradycardia Atrial Tachyarrhythmia

Interventions

Advisa IPGDEVICE

Implantable Pulse Generator will be implanted

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

IKEM

Prague, Czechia

Outcomes

Primary Outcomes

USADE at 1 month post implant

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

Time frame: 1 month

Secondary Outcomes

Advisa IPG system performance

System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.

Time frame: 1 month

Data from ClinicalTrials.gov

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