AdvisaTM IPG Clinical Evaluation Study

Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG

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).

Study Overview

• Status: Completed
• Conditions: Bradycardia; Atrial Tachyarrhythmia
• Intervention / Treatment: Device: Advisa IPG

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • IKEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implant Advisa IPG; Advisa IPG implant	Device: Advisa IPG; Implantable Pulse Generator will be implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
USADE at 1 month post implant	Confirm safety of the device by assessing the percentage of subjects with an unanticipated serious adverse device effect (USADE) at 1-month post-implant	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advisa IPG system performance	System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.	1 month

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Collaborators: Medtronic
• Investigators: Study Chair: Advisa Clinical Study Team, Medtronic Bakken Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 9, 2009

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bradycardia; Tachycardia
• Other Study ID Numbers: 114