BradycardiaNCT00839384
AdvisaTM IPG Clinical Evaluation Study
A study testing Advisa IPG in people with Bradycardia and Atrial Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bradycardia, Atrial Tachyarrhythmia
- What is being tested?
- Advisa IPG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Bradycardia, Atrial Tachyarrhythmia
- Being tested
- Advisa IPG
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advisa IPGDevice
Implantable Pulse Generator will be implanted
| Study group | Role | What they receive |
|---|---|---|
| Implant Advisa IPG | Experimental | Advisa IPG implant Receives: Device: Advisa IPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
Advisa IPG system performance
System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Advisa Clinical Study Team, Study chair, Medtronic Cardiac Rhythm and Heart Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839384
- Sponsor's protocol ID
- 114
- Status last verified
- Nov 2017
- First submitted
- 6 Feb 2009
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG
- ClinicalTrials.gov ID
- NCT00839384
- Acronym / sponsor ID
- 114
- Conditions
- Bradycardia, Atrial Tachyarrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Feb 2009 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Advisa IPG | Experimental | Device: Advisa IPGAdvisa IPG implant |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advisa IPGImplantable Pulse Generator will be implanted | Device | Implant Advisa IPG |
Primary outcome
USADE at 1 month post implant
Time frame: 1 month
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 secondary outcome
Advisa IPG system performance
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Advisa Clinical Study Team study chair
Medtronic Cardiac Rhythm and Heart Failure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advisa IPG in people with Bradycardia and Atrial Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USADE at 1 month post implant (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.