Trial Outcomes & Findings for Leadless Electrocardiogram (ECG) Evaluation Study (NCT NCT01297283)
NCT ID: NCT01297283
Last Updated: 2025-07-18
Results Overview
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.
COMPLETED
NA
195 participants
30 to 120 days
2025-07-18
Participant Flow
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.
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.
Participant milestones
| Measure |
Overall Subjects
Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
|
|---|---|
|
Overall Study
STARTED
|
195
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leadless Electrocardiogram (ECG) Evaluation Study
Baseline characteristics by cohort
| Measure |
Overall Subjects
n=195 Participants
|
|---|---|
|
Age, Continuous
|
80 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
|
BMC Index
|
24.75 kg/m²
n=5 Participants
|
|
Weight
|
71 Kilogramms
n=5 Participants
|
|
Height
|
1.69 meters
n=5 Participants
|
|
NYHA Class
Class I
|
6 participants
n=5 Participants
|
|
NYHA Class
Class II
|
41 participants
n=5 Participants
|
|
NYHA Class
Class III
|
105 participants
n=5 Participants
|
|
NYHA Class
Class IV
|
12 participants
n=5 Participants
|
|
NYHA Class
Not available
|
31 participants
n=5 Participants
|
|
LVEF
|
31 %
n=5 Participants
|
|
General cardiovascular history
Cardiomyopathy
|
187 participants
n=5 Participants
|
|
General cardiovascular history
Congenital Heart Disease
|
2 participants
n=5 Participants
|
|
General cardiovascular history
Congestive Heart Failure
|
29 participants
n=5 Participants
|
|
General cardiovascular history
Coronary artery disease
|
24 participants
n=5 Participants
|
|
General cardiovascular history
Hypertension
|
66 participants
n=5 Participants
|
|
General cardiovascular history
Myocardial infarction
|
25 participants
n=5 Participants
|
|
General cardiovascular history
Pulmonary hypertension (PH)
|
2 participants
n=5 Participants
|
|
General cardiovascular history
Valve dysfunction
|
26 participants
n=5 Participants
|
|
General cardiovascular history
Other cardiovascular history
|
17 participants
n=5 Participants
|
|
Cardiovascular Surgical History
NONE
|
65 participants
n=5 Participants
|
|
Cardiovascular Surgical History
Ablation
|
16 participants
n=5 Participants
|
|
Cardiovascular Surgical History
Coronary artery bypass graft (CABG)
|
11 participants
n=5 Participants
|
|
Cardiovascular Surgical History
Coronary artery intervention
|
43 participants
n=5 Participants
|
|
Cardiovascular Surgical History
Valve surgery
|
20 participants
n=5 Participants
|
|
Cardiovascular Surgical History
Other cardiovascular surgery
|
5 participants
n=5 Participants
|
|
Previous Device
CRT-D implant
|
6 participants
n=5 Participants
|
|
Previous Device
CRT-P implant
|
39 participants
n=5 Participants
|
|
Previous Device
ICD implant
|
1 participants
n=5 Participants
|
|
Previous Device
IPG implant
|
37 participants
n=5 Participants
|
|
Previous Device
other
|
5 participants
n=5 Participants
|
|
Atrial Arrhythmia History
NONE
|
86 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Atrial fibrillation
|
99 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Atrial flutter
|
12 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Atrial tachycardia
|
1 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Premature atrial complexes
|
1 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Sinus node dysfunction
|
6 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Supraventricular tachycardia
|
1 participants
n=5 Participants
|
|
Atrial Arrhythmia History
Other atrial arrhythmias
|
3 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
NONE
|
174 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Premature ventricular complexes
|
7 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Torsades de pointes
|
1 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Ventricular asystole
|
1 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Ventricular flutter
|
1 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Ventricular tachycardia, non-sustained
|
6 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Ventricular tachycardia, sustained monomorphic
|
1 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Ventricular tachycardia, sustained, unknown morpho
|
2 participants
n=5 Participants
|
|
Ventricular Arrhythmia History
Other ventricular arrhythmias
|
3 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
NONE
|
44 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
1st degree AV block
|
31 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
2nd degree AV block
|
10 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
3rd degree AV block
|
43 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
Intermediate bundle branch block
|
4 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
Left bundle branch block
|
96 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
Right bundle branch block
|
15 participants
n=5 Participants
|
|
AV Junctional Arrhythmia History
Other AV junctional arrhythmias and blocks
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 to 120 daysDuring 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.
Outcome measures
| Measure |
Overall Subjects
n=176 Participants
|
|---|---|
|
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 • Interval 0.95 to 1.0
|
|
Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.
All leads
|
0.96 proportion
Interval 0.92 to 0.98
|
|
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 • Interval 0.95 to 1.0
|
|
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 • Interval 0.95 to 1.0
|
SECONDARY outcome
Timeframe: 30 to 120 daysPopulation: Proportion of Patients Correctly Classified
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.
Outcome measures
| Measure |
Overall Subjects
n=176 Participants
|
|---|---|
|
Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.
|
0.51 proportion
Interval 0.43 to 0.59
|
SECONDARY outcome
Timeframe: 30 to 120 daysTwo 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 to 120 daysThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 to 120 daysThe 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 to 120 daysThe 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.
Outcome measures
Outcome data not reported
Adverse Events
Overall Subjects
Serious adverse events
| Measure |
Overall Subjects
n=195 participants at risk
|
|---|---|
|
Cardiac disorders
Cardiac decompensation / Global heart failure
|
3.1%
6/195 • Number of events 8
|
|
Cardiac disorders
Phrenic nerve stimulation
|
3.1%
6/195 • Number of events 6
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/195 • Number of events 3
|
|
Cardiac disorders
cardiogenic shock
|
1.5%
3/195 • Number of events 3
|
|
Cardiac disorders
AV node / His ablation
|
1.0%
2/195 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.51%
1/195 • Number of events 1
|
|
Cardiac disorders
LV lead dislodgement
|
0.51%
1/195 • Number of events 1
|
|
Cardiac disorders
LV lead threshold elevation
|
0.51%
1/195 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/195 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.51%
1/195 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
0.51%
1/195 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pocket hematoma
|
2.1%
4/195 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.51%
1/195 • Number of events 1
|
|
Vascular disorders
Abdnominal aortic aneurysm
|
0.51%
1/195 • Number of events 1
|
|
Hepatobiliary disorders
hepatocellular failure
|
0.51%
1/195 • Number of events 1
|
|
Blood and lymphatic system disorders
allergy to iodine
|
0.51%
1/195 • Number of events 1
|
|
Endocrine disorders
hyperthyroidism
|
0.51%
1/195 • Number of events 1
|
|
General disorders
fever
|
0.51%
1/195 • Number of events 1
|
|
General disorders
multiviceral failure and cancer
|
0.51%
1/195 • Number of events 1
|
|
General disorders
general fatigue sensation and feet formications
|
0.51%
1/195 • Number of events 1
|
Other adverse events
| Measure |
Overall Subjects
n=195 participants at risk
|
|---|---|
|
Cardiac disorders
coronary sinus dissection
|
0.51%
1/195 • Number of events 1
|
|
Blood and lymphatic system disorders
Slight deglobulisation
|
0.51%
1/195 • Number of events 1
|
|
Gastrointestinal disorders
colonic ischemia
|
0.51%
1/195 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place