NCT00839384

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 3, 2025

Status Verified

November 1, 2017

Enrollment Period

5 months

First QC Date

February 6, 2009

Last Update Submit

June 30, 2025

Conditions

BradycardiaAtrial Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Advisa IPG system performance

    1 month

Study Arms (1)

Implant Advisa IPG

EXPERIMENTAL

Advisa IPG implant

Device: Advisa IPG

Interventions

Advisa IPGDEVICE

Implantable Pulse Generator will be implanted

Implant Advisa IPG

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IKEM

Prague, Czechia

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Advisa Clinical Study Team

    Medtronic Cardiac Rhythm and Heart Failure

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 3, 2025

Record last verified: 2017-11

Locations

CZ(1)