AdvisaTM IPG Clinical Evaluation Study

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839384
• Other study ID #: 114
• Status: Completed
• Phase: N/A
• First received: February 6, 2009
• Last updated: November 8, 2017
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: November 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Tachyarrhythmia
• Bradycardia
• Tachycardia

Intervention

Device:
• Advisa IPG
Implantable Pulse Generator will be implanted

Locations

Country	Name	City	State
Czechia	IKEM	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Advisa IPG system performance	System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.	1 month