AdvisaTM IPG Clinical Evaluation Study
Recruitment status was Recruiting
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG|
- 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 ] [ Designated as safety issue: No ]
- System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Device: Advisa IPG
Implantable Pulse Generator will be implanted
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.
|Contact: Advisa clinical study firstname.lastname@example.org|
|City, Czech Republic|
|Contact: Doctor Doctor, MD|
|Principal Investigator: Doctor Doctor, MD|
|Study Chair:||Advisa Clinical Study Team||Medtronic Bakken Research Center|