Atrial FibrillationPhase 4NCT00157781
LEAF - Low Energy In Atrial Fibrillation
A Phase 4 study testing Medtronic AT500 in people with Atrial Fibrillation and Atrial Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure.
Trial summary
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Tachyarrhythmia
- What is being tested?
- Medtronic AT500
- Type of treatment
- Medical device
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Nov 2003
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.
Who cannot join
- Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.
About this study
Official title: Low Energy in Atrial Fibrillation AF Phase IV Study in AT/AF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.
Read the detailed description
Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT. The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden, improving QOL and reducing symptoms and costs. Method. 243 pts are implanted with the AT500TM and followed at 1, 7 and 13 months after implant. All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months. One month after implantation patients are randomized either to a six month therapy phase (activation of preventive and ATP pacing) or a six month observation phase (No AT prevention nor Therapy). Crossover (CO) takes place at seven months after implant and the endpoint is reached at 13 months. Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods. At each follow-up, a Save to Disk (STD) of device-stored AT episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.
- Conditions
- Atrial Fibrillation, Atrial Tachyarrhythmia
- Being tested
- Medtronic AT500
- Keywords
- Atrial Fibrillation, Atrial Tachyarrhythmia, Pacing, Electrophysiology
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic AT500Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that AT 500 algorithms decrease AF Burden
Secondary outcomes (5)
Characterize the efficiency of prevention and termination algorithms on the Quality of Life of patients
Characterize the correlation between symptoms and stored EGM's
Determine the total number of AF/AT episodes and observe the decrement of their occurrence frequency due to prevention algorithms.
Determine the number of Hospitalization, physician visits…: economical analyze
Analyze the episode onset mechanism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2000
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 237 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Kacet Salem, Prof., Principal investigator, University Hospital, LilleMabo Philippe, Prof., Study chair, Rennes University HospitalPisipia André, Dr., Study chair, Hopital St Joseph - Marseille - FranceFrank Robert, Dr., Study chair, CHU Pitié-Salpétrière - Paris - FranceAttuel Patrick, Dr., Study chair, Clinique Parly 2 - le Chesnay - FranceAliot Etienne, Prof., Study chair, CHU Nancy - Francele Heuzey Jean Yves, Prof., Study chair, HEGP Paris - FranceDavy Jean Marc, prof., Study chair, CHU Montpellier - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157781
- Sponsor's protocol ID
- 124
- Other IDs
- CP00/63 (CCPPRB Lille France), 2001/08/010 (AFSSAPS France)
- Status last verified
- Jan 2018
- First submitted
- 8 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- 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
- Low Energy in Atrial Fibrillation AF Phase IV Study in AT/AF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker
- ClinicalTrials.gov ID
- NCT00157781
- Acronym / sponsor ID
- 124
- Conditions
- Atrial Fibrillation, Atrial Tachyarrhythmia
- Keywords
- Atrial Fibrillation, Atrial Tachyarrhythmia, Pacing, Electrophysiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Aug 2000
- Study completion
- Nov 2003
- First posted
- 12 Sep 2005 (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 study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.
Detailed description
Aim. More than 30% of patients (pts) implanted with a pacemaker are known to have atrial tachyarrhythmias (AT) despite medical treatment and about 20% of pts experience AT prior to implant. The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT. The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden, improving QOL and reducing symptoms and costs. Method. 243 pts are implanted with the AT500TM and followed at 1, 7 and 13 months after implant. All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months. One month after implantation patients are randomized either to a six month therapy phase (activation of preventive and ATP pacing) or a six month observation phase (No AT prevention nor Therapy). Crossover (CO) takes place at seven months after implant and the endpoint is reached at 13 months. Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods. At each follow-up, a Save to Disk (STD) of device-stored AT episodes is performed and hospitalization, visits and/or other examinations are reported for future cost evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACC/AHA Class I or II indication for dual chamber pacing and two symptomatic atrial fibrillation or flutter episodes in the three months prior to implant as well as ECG documentation of at least one episode in the prior year.
Key exclusion criteria (1 listed)
- Patients with permanent/persistent AF, an indication for an implantable cardioverter defibrillator or class IV heart failure.
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 |
|---|---|---|
| Medtronic AT500 | Device | – |
Primary outcome
Demonstrate that AT 500 algorithms decrease AF Burden
5 secondary outcomes
Characterize the efficiency of prevention and termination algorithms on the Quality of Life of patients
Characterize the correlation between symptoms and stored EGM's
Determine the total number of AF/AT episodes and observe the decrement of their occurrence frequency due to prevention algorithms.
Determine the number of Hospitalization, physician visits…: economical analyze
Analyze the episode onset mechanism
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.
Kacet Salem, Prof. principal investigator
University Hospital, Lille
Mabo Philippe, Prof. study chair
Rennes University Hospital
Pisipia André, Dr. study chair
Hopital St Joseph - Marseille - France
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medtronic AT500 in people with Atrial Fibrillation and Atrial Tachyarrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure.
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 1 inclusion and 1 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.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demonstrate that AT 500 algorithms decrease AF Burden. 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.