AdvisaTM IPG Clinical Evaluation Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Medtronic Bakken Research Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medtronic Bakken Research Center
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00839384
First received: February 6, 2009
Last updated: February 23, 2009
Last verified: February 2009
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Bradycardia Atrial Tachyarrhythmia |
Device: Advisa IPG |
| Study Type: | Interventional |
| 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 |
Further study details as provided by Medtronic Bakken Research Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Advisa IPG
|
Device: Advisa IPG
Implantable Pulse Generator will be implanted
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839384
Contacts
| Contact: Advisa clinical study team | advisa.brc@medtronic.com |
Locations
| Czech Republic | |
| Hospital | Recruiting |
| City, Czech Republic | |
| Contact: Doctor Doctor, MD | |
| Principal Investigator: Doctor Doctor, MD | |
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
| Study Chair: | Advisa Clinical Study Team | Medtronic Bakken Research Center |
More Information
No publications provided
| Responsible Party: | CRDM CE Clinical Department, Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00839384 History of Changes |
| Other Study ID Numbers: | 114 |
| Study First Received: | February 6, 2009 |
| Last Updated: | February 23, 2009 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Germany: German Institute of Medical Documentation and Information Netherlands: Ministry of Health, Welfare and Sport Norway: Directorate of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Additional relevant MeSH terms:
|
Tachycardia Bradycardia Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013