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AdvisaTM IPG Clinical Evaluation Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT00839384

AdvisaTM IPG Clinical Evaluation Study

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).

Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

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.

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 3, 2025Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment79

Start dateFeb 2009

Last updatedJul 3, 2025

Condition

Bradycardia Atrial Tachyarrhythmia

Locations shown

IKEM

Prague

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions