AdvisaTM IPG Clinical Evaluation Study
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|ClinicalTrials.gov Identifier: NCT00839384|
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia Atrial Tachyarrhythmia||Device: Advisa IPG||Not Applicable|
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|
|Actual Primary Completion Date :||July 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839384
|Study Chair:||Advisa Clinical Study Team||Medtronic Bakken Research Center|