Heart Failure
Conditions
Keywords
Heart failure, Cardiac resynchronization, Leadless ECG, Follow-up
Brief 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. 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.
Interventions
OTHERLECG first
Measurement of the pacing threshold with the support of a leadless ECG
OTHERProgrammer ECG first
Pacing threshold measurements are done with the support of the programmer ECG
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patient with a CRT-P indication and * patient who has signed an informed consent form.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer. | 30 to 120 days | 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. |
| Evaluation of the Stability of LECG Performance Over Time. | 30 to 120 days | 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). |
| Quality of LECG in New Devices Versus Device Replacements. | 30 to 120 days | 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. |
| Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality. | 30 to 120 days | 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. |
| 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. | 30 to 120 days | 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. |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Subjects | 195 |
| Total | 195 |
Baseline characteristics
| Characteristic | Overall Subjects |
|---|---|
| Age, Continuous | 80 years |
| Atrial Arrhythmia History Atrial fibrillation | 99 participants |
| Atrial Arrhythmia History Atrial flutter | 12 participants |
| Atrial Arrhythmia History Atrial tachycardia | 1 participants |
| Atrial Arrhythmia History NONE | 86 participants |
| Atrial Arrhythmia History Other atrial arrhythmias | 3 participants |
| Atrial Arrhythmia History Premature atrial complexes | 1 participants |
| Atrial Arrhythmia History Sinus node dysfunction | 6 participants |
| Atrial Arrhythmia History Supraventricular tachycardia | 1 participants |
| AV Junctional Arrhythmia History 1st degree AV block | 31 participants |
| AV Junctional Arrhythmia History 2nd degree AV block | 10 participants |
| AV Junctional Arrhythmia History 3rd degree AV block | 43 participants |
| AV Junctional Arrhythmia History Intermediate bundle branch block | 4 participants |
| AV Junctional Arrhythmia History Left bundle branch block | 96 participants |
| AV Junctional Arrhythmia History NONE | 44 participants |
| AV Junctional Arrhythmia History Other AV junctional arrhythmias and blocks | 5 participants |
| AV Junctional Arrhythmia History Right bundle branch block | 15 participants |
| BMC Index | 25.64 kg/m² STANDARD_DEVIATION 4.38 |
| Cardiovascular Surgical History Ablation | 16 participants |
| Cardiovascular Surgical History Coronary artery bypass graft (CABG) | 11 participants |
| Cardiovascular Surgical History Coronary artery intervention | 43 participants |
| Cardiovascular Surgical History NONE | 65 participants |
| Cardiovascular Surgical History Other cardiovascular surgery | 5 participants |
| Cardiovascular Surgical History Valve surgery | 20 participants |
| General cardiovascular history Cardiomyopathy | 187 participants |
| General cardiovascular history Congenital Heart Disease | 2 participants |
| General cardiovascular history Congestive Heart Failure | 29 participants |
| General cardiovascular history Coronary artery disease | 24 participants |
| General cardiovascular history Hypertension | 66 participants |
| General cardiovascular history Myocardial infarction | 25 participants |
| General cardiovascular history Other cardiovascular history | 17 participants |
| General cardiovascular history Pulmonary hypertension (PH) | 2 participants |
| General cardiovascular history Valve dysfunction | 26 participants |
| Height | 1.68 meters STANDARD_DEVIATION 0.09 |
| LVEF | 31.67 % STANDARD_DEVIATION 8.18 |
| NYHA Class Class I | 6 participants |
| NYHA Class Class II | 41 participants |
| NYHA Class Class III | 105 participants |
| NYHA Class Class IV | 12 participants |
| NYHA Class Not available | 31 participants |
| Previous Device CRT-D implant | 6 participants |
| Previous Device CRT-P implant | 39 participants |
| Previous Device ICD implant | 1 participants |
| Previous Device IPG implant | 37 participants |
| Previous Device other | 5 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 145 Participants |
| Ventricular Arrhythmia History NONE | 174 participants |
| Ventricular Arrhythmia History Other ventricular arrhythmias | 3 participants |
| Ventricular Arrhythmia History Premature ventricular complexes | 7 participants |
| Ventricular Arrhythmia History Torsades de pointes | 1 participants |
| Ventricular Arrhythmia History Ventricular asystole | 1 participants |
| Ventricular Arrhythmia History Ventricular flutter | 1 participants |
| Ventricular Arrhythmia History Ventricular tachycardia, non-sustained | 6 participants |
| Ventricular Arrhythmia History Ventricular tachycardia, sustained monomorphic | 1 participants |
| Ventricular Arrhythmia History Ventricular tachycardia, sustained, unknown morpho | 2 participants |
| Weight | 72.9 Kilogramms STANDARD_DEVIATION 14.37 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 195 |
| serious Total, serious adverse events | 35 / 195 |
Outcome results
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.
Time frame: 30 to 120 days
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Overall Subjects | Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. | Atrial lead | 0.99 proportion | 95% Confidence Interval 0.41 |
| Overall Subjects | Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. | RV Lead | 0.98 proportion | 95% Confidence Interval 0.56 |
| Overall Subjects | Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. | LV Lead | 0.98 proportion | 95% Confidence Interval 1.19 |
| Overall Subjects | Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. | All leads | 0.96 proportion | — |
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.
Time frame: 30 to 120 days
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: * 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.
Time frame: 30 to 120 days
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.
Time frame: 30 to 120 days
Population: Proportion of Patients Correctly Classified
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Subjects | Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer. | 0.51 proportion |
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: * 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).
Time frame: 30 to 120 days
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: * 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.
Time frame: 30 to 120 days