Status:
COMPLETED
AdvisaTM IPG Clinical Evaluation Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Bradycardia
Atrial Tachyarrhythmia
Eligibility:
All Genders
18-100 years
Phase:
NA
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 prospect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00839384
Start Date
February 1 2009
End Date
July 1 2009
Last Update
July 3 2025
Active Locations (1)
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1
IKEM
Prague, Czechia