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AdvisaTM IPG Clinical Evaluation Study

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

NCT00839384•Medtronic Cardiac Rhythm and Heart Failure

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

February 1, 2009

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

July 3, 2025

Enrollment

ACTUAL participants

Conditions

BradycardiaAtrial Tachyarrhythmia

Interventions

Advisa IPG

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

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RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291

BradycardiaHeart Failure

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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: March 29, 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.

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AdvisaTM IPG Clinical Evaluation Study

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery