AdvisaTM IPG Clinical Evaluation Study
|ClinicalTrials.gov Identifier: NCT00839384|
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment|
|Bradycardia Atrial Tachyarrhythmia||Device: Advisa IPG|
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)|
|Official Title:||Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG|
|Actual Study Start Date :||February 2009|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
Experimental: Implant Advisa IPG
Advisa IPG implant
Device: Advisa IPG
Implantable Pulse Generator will be implanted
- 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
- Advisa IPG system performance [ Time Frame: 1 month ]System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839384
|Study Chair:||Advisa Clinical Study Team||Medtronic Bakken Research Center|