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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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Bradycardia
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014