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Leadless Electrocardiogram (ECG) Evaluation Study (LECG)

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ClinicalTrials.gov Identifier: NCT01297283
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : April 1, 2014
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Heart Failure
Interventions Other: LECG first
Other: Programmer ECG first
Enrollment 195
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.
Arm/Group Title Overall Subjects
Hide Arm/Group Description Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
Period Title: Overall Study
Started 195
Completed 176
Not Completed 19
Arm/Group Title Overall Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants
77.6  (9.83)
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 195 participants
80
(74 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants
Female
50
  25.6%
Male
145
  74.4%
BMC Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 195 participants
25.64  (4.38)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogramms
Number Analyzed 195 participants
72.9  (14.37)
Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kilogramms
Number Analyzed 195 participants
71
(63 to 81)
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 195 participants
1.68  (0.09)
Height  
Median (Inter-Quartile Range)
Unit of measure:  Meters
Number Analyzed 195 participants
1.69
(1.62 to 1.75)
BMC Index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m²
Number Analyzed 195 participants
24.75
(22.64 to 27.76)
NYHA Class  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
Class I 6
Class II 41
Class III 105
Class IV 12
Not available 31
LVEF  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 195 participants
31.67  (8.18)
LVEF  
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 195 participants
31
(25 to 35)
General cardiovascular history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
Cardiomyopathy 187
Congenital Heart Disease 2
Congestive Heart Failure 29
Coronary artery disease 24
Hypertension 66
Myocardial infarction 25
Pulmonary hypertension (PH) 2
Valve dysfunction 26
Other cardiovascular history 17
Cardiovascular Surgical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
NONE 65
Ablation 16
Coronary artery bypass graft (CABG) 11
Coronary artery intervention 43
Valve surgery 20
Other cardiovascular surgery 5
Previous Device  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
CRT-D implant 6
CRT-P implant 39
ICD implant 1
IPG implant 37
other 5
Atrial Arrhythmia History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
NONE 86
Atrial fibrillation 99
Atrial flutter 12
Atrial tachycardia 1
Premature atrial complexes 1
Sinus node dysfunction 6
Supraventricular tachycardia 1
Other atrial arrhythmias 3
Ventricular Arrhythmia History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
NONE 174
Premature ventricular complexes 7
Torsades de pointes 1
Ventricular asystole 1
Ventricular flutter 1
Ventricular tachycardia, non-sustained 6
Ventricular tachycardia, sustained monomorphic 1
Ventricular tachycardia, sustained, unknown morpho 2
Other ventricular arrhythmias 3
AV Junctional Arrhythmia History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 195 participants
NONE 44
1st degree AV block 31
2nd degree AV block 10
3rd degree AV block 43
Intermediate bundle branch block 4
Left bundle branch block 96
Right bundle branch block 15
Other AV junctional arrhythmias and blocks 5
1.Primary Outcome
Title Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 176
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion
Atrial lead
0.99
(0.95 to 1.00)
RV Lead
0.98
(0.95 to 1.00)
LV Lead
0.98
(0.95 to 1.00)
All leads
0.96
(0.92 to 0.98)
2.Secondary Outcome
Title Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of Patients Correctly Classified
Arm/Group Title Overall Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 176
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion
0.51
(0.43 to 0.59)
3.Secondary Outcome
Title Evaluation of the Stability of LECG Performance Over Time.
Hide Description

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
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Quality of LECG in New Devices Versus Device Replacements.
Hide Description

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
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.
Hide Description

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
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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.
Hide Description

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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall Subjects
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Overall Subjects
Affected / at Risk (%) # Events
Total   35/195 (17.95%)    
Blood and lymphatic system disorders   
anemia  1/195 (0.51%)  1
allergy to iodine  1/195 (0.51%)  1
Cardiac disorders   
Cardiac decompensation / Global heart failure  6/195 (3.08%)  8
Phrenic nerve stimulation  6/195 (3.08%)  6
Atrial fibrillation  3/195 (1.54%)  3
cardiogenic shock  3/195 (1.54%)  3
AV node / His ablation  2/195 (1.03%)  2
Pericardial effusion  1/195 (0.51%)  1
LV lead dislodgement  1/195 (0.51%)  1
LV lead threshold elevation  1/195 (0.51%)  1
Endocrine disorders   
hyperthyroidism  1/195 (0.51%)  1
General disorders   
fever  1/195 (0.51%)  1
multiviceral failure and cancer  1/195 (0.51%)  1
general fatigue sensation and feet formications  1/195 (0.51%)  1
Hepatobiliary disorders   
hepatocellular failure  1/195 (0.51%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  2/195 (1.03%)  2
pulmonary edema  1/195 (0.51%)  1
Skin and subcutaneous tissue disorders   
Pocket hematoma  4/195 (2.05%)  4
eczema  1/195 (0.51%)  1
Vascular disorders   
Abdnominal aortic aneurysm  1/195 (0.51%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Subjects
Affected / at Risk (%) # Events
Total   3/195 (1.54%)    
Blood and lymphatic system disorders   
Slight deglobulisation  1/195 (0.51%)  1
Cardiac disorders   
coronary sinus dissection  1/195 (0.51%)  1
Gastrointestinal disorders   
colonic ischemia  1/195 (0.51%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Latifa Foudali
Organization: Medtronic
Phone: +33 631992144
EMail: latifa.foudali@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01297283    
Other Study ID Numbers: Leadless ECG Evaluation Study
First Submitted: February 3, 2011
First Posted: February 16, 2011
Results First Submitted: December 23, 2013
Results First Posted: April 1, 2014
Last Update Posted: March 21, 2017