AdvisaTM IPG Clinical Evaluation Study
Recruitment status was: Recruiting
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839384
|City, Czech Republic|
|Study Chair:||Advisa Clinical Study Team||Medtronic Bakken Research Center|