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AdvisaTM IPG Clinical Evaluation Study

Primary Purpose

Bradycardia, Atrial Tachyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Advisa IPG
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IKEM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant Advisa IPG

Arm Description

Advisa IPG implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2009
Last Updated
November 8, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00839384
Brief Title
AdvisaTM IPG Clinical Evaluation Study
Official Title
Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Atrial Tachyarrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implant Advisa IPG
Arm Type
Experimental
Arm Description
Advisa IPG implant
Intervention Type
Device
Intervention Name(s)
Advisa IPG
Intervention Description
Implantable Pulse Generator will be implanted
Primary Outcome Measure Information:
Title
USADE at 1 month post implant
Description
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 Outcome Measure Information:
Title
Advisa IPG system performance
Description
System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Advisa Clinical Study Team
Organizational Affiliation
Medtronic Bakken Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
IKEM
City
Prague
Country
Czechia

12. IPD Sharing Statement

Learn more about this trial

AdvisaTM IPG Clinical Evaluation Study

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