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AdvisaTM IPG Clinical Evaluation Study

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ClinicalTrials.gov Identifier: NCT00839384
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Bradycardia Atrial Tachyarrhythmia Device: Advisa IPG Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG
Actual Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Implant Advisa IPG
Advisa IPG implant
Device: Advisa IPG
Implantable Pulse Generator will be implanted



Primary Outcome Measures :
  1. USADE at 1 month post implant [ Time Frame: 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 :
  1. Advisa IPG system performance [ Time Frame: 1 month ]
    System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839384


Locations
Czechia
IKEM
Prague, Czechia
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Study Chair: Advisa Clinical Study Team Medtronic Bakken Research Center

Responsible Party: CRDM CE Clinical Department, Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00839384     History of Changes
Other Study ID Numbers: 114
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Bradycardia
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes