AdvisaTM IPG Clinical Evaluation Study

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-07-31

Brief Summary

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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).

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Detailed Description

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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

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Bradycardia Atrial Tachyarrhythmia

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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Implant Advisa IPG

Advisa IPG implant

Group Type EXPERIMENTAL

Advisa IPG

Intervention Type DEVICE

Implantable Pulse Generator will be implanted

Interventions

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Advisa IPG

Implantable Pulse Generator will be implanted

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No