Heart FailureLECGNCT01297283
Leadless Electrocardiogram (ECG) Evaluation Study
A study testing LECG first and Programmer ECG first in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
Trial summary
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- LECG first and Programmer ECG first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patient with a CRT-P indication and
- patient who has signed an informed consent form.
Who cannot join
- patient younger than 18 years and/or
- unable to complete the 1-Month Follow-up visit and/or
- legally incompetent or illiterate and therefore unable to provide an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.
The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.
Read the detailed description
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine. The LECG signals are measured from three electrodes mounted on the outside of the pacemaker housing and provides an electrical far field signal of the electrical activity of the heart. The LECG provides three ECG channels as different projections of the electrical activity of the heart, similar to the surface ECG. Clinical interest of LECG is threefold. First, ECG recordings are routinely used to perform pacemaker and cardiac resynchronization systems in-office follow-up mainly to determine pacing thresholds. Connection of ECG electrodes to the patient as well as the time needed to acquire an acceptable ECG signal during routine follow-up could be saved using LECG which would make follow-up easier and less time consuming. Secondly, connecting ECG electrodes requires the patient to be present at the clinic for the follow-up. Use of LECG in conjunction with a transmitting system will allow remote patient follow-up. In that case, correct ventricular capture confirmation by the LECG is of key importance. Finally, LECG stored in device memory at the time of an arrhythmia episode occurrence, can help better classify it.
The following factors might influence the quality of the LECG and/or the axis of the LECG:
- temporal changes of the electrode tissue interface due to device pocket healing process
- changes in device position and orientation over time
- body motion
- poor LECG contact due to oversized device pocket with replacement procedure. The purpose of this study is to obtain more data on leadless ECG (LECG) to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.
- Conditions
- Heart Failure
- Being tested
- LECG first, Programmer ECG first
- Keywords
- Heart failure, Cardiac resynchronization, Leadless ECG, Follow-up
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LECG firstOther
Measurement of the pacing threshold with the support of a leadless ECG
Programmer ECG firstOther
Pacing threshold measurements are done with the support of the programmer ECG
| Study group | Role | What they receive |
|---|---|---|
| Leadless ECG first | Experimental | Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device Receives: Other: LECG first |
| Programmer ECG first | Active comparator | Measurements of pacing thresholds are done first with the support of the programmer ECG Receives: Other: Programmer ECG first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.
During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.
Measured: 30 to 120 days
Secondary outcomes (5)
Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.
The investigator will simulate loss of capture (LOC) at 1-Month Follow-Up visit by printing strips of LOC in both ventricular leads, LOC in LV lead only, LOC in RV lead only, no LOC. One strip randomly selected among them by the study manager will be submitted to an independent reviewer. With help of the PHD template LECG strips (intrinsic, RV paced, LV paced, BiV paced) of this patient, he/she will determine which lead is capturing.
The endpoint is the proportion of correct classifications of ventricular capture done by then independent reviewer of LECG.
Measured: 30 to 120 days
Evaluation of the Stability of LECG Performance Over Time.
Two parameters will be used to evaluate LECG changes between PHD and 1-Month on the same LECG vector: intrinsic R wave amplitude and P waves visibility (selection the LECG vector at PHD with best combination of the highest R wave and most visible P wave).
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.
The endpoints evaluated are:
- mean R wave changes from PHD to 1-month
- proportion of patients with stable P wave visibility at PHD and 1-Month (meaning both visits visible or both visits not visible).
Measured: 30 to 120 days
Quality of LECG in New Devices Versus Device Replacements.
The two following parameters will be used to compare the quality of LECG in new implants versus device replacements at PHD and 1-Month on the same LECG vector:
- Intrinsic R wave amplitude
- P waves visibility The LECG vector at PHD with best combination of the highest R wave and most visible P wave will be selected.
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.
The endpoints will be:
- comparison of mean R wave values at PHD and 1-month
- comparison of proportion of patients with P wave visible at PHD and 1-month.
Measured: 30 to 120 days
Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.
The intrinsic R wave amplitude and P waves visibility will be taken to evaluate the effect of posture changes and artifact-inducing maneuvers on the quality of LECG at the 1-Month Follow-Up visit (LECG vector with best combination of the highest R wave and most visible P wave).
The endpoints will be R wave amplitude and P wave visibility in different positions (meaning visible or not visible in both positions).
R wave changes and proportion of patients with stable P waves visibility at lying position versus other positions will be calculated by an independent reviewer.
Measured: 30 to 120 days
Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.
The following factors will be evaluated to investigate whether they influence the LECG quality:
- device position (subcutaneous, submuscular, etc)
- device rotation
- device fixation
- device side facing the skin
- position of lead loops in the pocket
- use of antibiotics in the pocket
- skin type (loose, normal, firm)
- body mass index (BMI)
The endpoints will be:
- describe R wave amplitude values
- describe proportion of patients with P wave visible on intrinsic LECG strips recorded at 1-Month FU.
Measured: 30 to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise HIDDEN-LUCET, MD, Principal investigator, Hôpital La Pitié Salpêtrière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297283
- Sponsor's protocol ID
- Leadless ECG Evaluation Study
- Acronym
- LECG
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2011
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.
- ClinicalTrials.gov ID
- NCT01297283
- Acronym / sponsor ID
- LECG / Leadless ECG Evaluation Study
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac resynchronization, Leadless ECG, Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine.
The purpose of the study is to obtain more data on leadless ECG to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.
Detailed description
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG machine. The LECG signals are measured from three electrodes mounted on the outside of the pacemaker housing and provides an electrical far field signal of the electrical activity of the heart. The LECG provides three ECG channels as different projections of the electrical activity of the heart, similar to the surface ECG. Clinical interest of LECG is threefold. First, ECG recordings are routinely used to perform pacemaker and cardiac resynchronization systems in-office follow-up mainly to determine pacing thresholds. Connection of ECG electrodes to the patient as well as the time needed to acquire an acceptable ECG signal during routine follow-up could be saved using LECG which would make follow-up easier and less time consuming. Secondly, connecting ECG electrodes requires the patient to be present at the clinic for the follow-up. Use of LECG in conjunction with a transmitting system will allow remote patient follow-up. In that case, correct ventricular capture confirmation by the LECG is of key importance. Finally, LECG stored in device memory at the time of an arrhythmia episode occurrence, can help better classify it.
The following factors might influence the quality of the LECG and/or the axis of the LECG:
- temporal changes of the electrode tissue interface due to device pocket healing process
- changes in device position and orientation over time
- body motion
- poor LECG contact due to oversized device pocket with replacement procedure. The purpose of this study is to obtain more data on leadless ECG (LECG) to determine whether LECG during standard CRT follow-up can indeed adequately replace surface ECG and to evaluate if it can be used during remote follow-up evaluations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leadless ECG first | Experimental | Other: LECG firstMeasurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device |
| Programmer ECG first | Active comparator | Other: Programmer ECG firstMeasurements of pacing thresholds are done first with the support of the programmer ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with a CRT-P indication and
- patient who has signed an informed consent form.
Key exclusion criteria (3 listed)
- patient younger than 18 years and/or
- unable to complete the 1-Month Follow-up visit and/or
- legally incompetent or illiterate and therefore unable to provide an informed consent
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 |
|---|---|---|
| LECG firstMeasurement of the pacing threshold with the support of a leadless ECG | Other | Leadless ECG first |
| Programmer ECG firstPacing threshold measurements are done with the support of the programmer ECG | Other | Programmer ECG first |
Primary outcome
Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.
Time frame: 30 to 120 days
During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.
5 secondary outcomes
Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.
Time frame: 30 to 120 days
Evaluation of the Stability of LECG Performance Over Time.
Time frame: 30 to 120 days
Quality of LECG in New Devices Versus Device Replacements.
Time frame: 30 to 120 days
Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.
Time frame: 30 to 120 days
Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.
Time frame: 30 to 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No sharing
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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.
Françoise HIDDEN-LUCET, MD principal investigator
Hôpital La Pitié Salpêtrière, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LECG first and Programmer ECG first in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
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 2 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 18 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 France. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. (time frame: 30 to 120 days). 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 18 Jul 2025.