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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leadless ECG first | Experimental | Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device |
|
| Programmer ECG first | Active Comparator | Measurements of pacing thresholds are done first with the support of the programmer ECG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LECG first | Other | Measurement of the pacing threshold with the support of a leadless ECG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise HIDDEN-LUCET, MD | Hôpital La Pitié Salpêtrière, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital La Pitié Salpêtrière | Paris | 75013 | France |
No sharing
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The point of enrollment was defined as the time before device implant at which a patient has signed and dated the Informed Consent Form. At that point, the patient needed to be followed for the duration of the study (until the 1-Month Follow-Up visit) unless a Study Exit Form was completed.
200 patients were enrolledand were followed for at least 1 month in 25 institutions in France (max 50 patients per center). The first patient was enrolled on 16th of September 2010. The last patient was enrolled on the 13th of September 2011. The last follow-up visit took place on 5th of December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Subjects | Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | proportion | 30 to 120 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac decompensation / Global heart failure | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coronary sinus dissection | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Latifa Foudali | Medtronic | +33 631992144 | latifa.foudali@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Programmer ECG first | Other | Pacing threshold measurements are done with the support of the programmer ECG |
|
| 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:
| 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:
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer. The endpoints will be:
| 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. | 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:
The endpoints will be:
| 30 to 120 days |
| years |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMC Index | Mean | Standard Deviation | kg/m² |
|
| Weight | Mean | Standard Deviation | Kilogramms |
|
| Weight | Median | Inter-Quartile Range | Kilogramms |
|
| Height | Mean | Standard Deviation | meters |
|
| Height | Median | Inter-Quartile Range | meters |
|
| BMC Index | Median | Inter-Quartile Range | kg/m² |
|
| NYHA Class | Number | participants |
|
| LVEF | Mean | Standard Deviation | % |
|
| LVEF | Median | Inter-Quartile Range | % |
|
| General cardiovascular history | Number | participants |
|
| Cardiovascular Surgical History | Number | participants |
|
| Previous Device | Number | participants |
|
| Atrial Arrhythmia History | Number | participants |
|
| Ventricular Arrhythmia History | Number | participants |
|
| AV Junctional Arrhythmia History | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Proportion of Patients Correctly Classified | Posted | Number | 95% Confidence Interval | proportion | 30 to 120 days |
|
|
|
| Secondary | 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:
| Not Posted | 30 to 120 days | Participants |
| Secondary | 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:
R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer. The endpoints will be:
| Not Posted | 30 to 120 days | Participants |
| Secondary | 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. | Not Posted | 30 to 120 days | Participants |
| Secondary | 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:
The endpoints will be:
| Not Posted | 30 to 120 days | Participants |
| 35 |
| 195 |
| 3 |
| 195 |
| Phrenic nerve stimulation | Cardiac disorders |
|
| Atrial fibrillation | Cardiac disorders |
|
| cardiogenic shock | Cardiac disorders |
|
| AV node / His ablation | Cardiac disorders |
|
| Pericardial effusion | Cardiac disorders |
|
| LV lead dislodgement | Cardiac disorders |
|
| LV lead threshold elevation | Cardiac disorders |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
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| pulmonary edema | Respiratory, thoracic and mediastinal disorders |
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| anemia | Blood and lymphatic system disorders |
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| Pocket hematoma | Skin and subcutaneous tissue disorders |
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| eczema | Skin and subcutaneous tissue disorders |
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| Abdnominal aortic aneurysm | Vascular disorders |
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| hepatocellular failure | Hepatobiliary disorders |
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| allergy to iodine | Blood and lymphatic system disorders |
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| hyperthyroidism | Endocrine disorders |
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| fever | General disorders |
|
| multiviceral failure and cancer | General disorders |
|
| general fatigue sensation and feet formications | General disorders |
|
| Slight deglobulisation | Blood and lymphatic system disorders |
|
| colonic ischemia | Gastrointestinal disorders |
|
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