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Leadless Electrocardiogram (ECG) Evaluation Study (LECG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01297283
First received: February 3, 2011
Last updated: February 14, 2014
Last verified: February 2014
Results First Received: December 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Heart Failure
Interventions: Other: LECG first
Other: Programmer ECG first

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Overall Subjects Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device

Participant Flow:   Overall Study
    Overall Subjects
STARTED   195 
COMPLETED   176 
NOT COMPLETED   19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Subjects No text entered.

Baseline Measures
   Overall Subjects 
Overall Participants Analyzed 
[Units: Participants]
 195 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.6  (9.83) 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 80 
 (74 to 84) 
Gender 
[Units: Participants]
 
Female   50 
Male   145 
BMC Index 
[Units: Kg/m²]
Mean (Standard Deviation)
 25.64  (4.38) 
Weight 
[Units: Kilogramms]
Mean (Standard Deviation)
 72.9  (14.37) 
Weight 
[Units: Kilogramms]
Median (Inter-Quartile Range)
 71 
 (63 to 81) 
Height 
[Units: Meters]
Mean (Standard Deviation)
 1.68  (0.09) 
Height 
[Units: Meters]
Median (Inter-Quartile Range)
 1.69 
 (1.62 to 1.75) 
BMC Index 
[Units: Kg/m²]
Median (Inter-Quartile Range)
 24.75 
 (22.64 to 27.76) 
NYHA Class 
[Units: Participants]
 
Class I   6 
Class II   41 
Class III   105 
Class IV   12 
Not available   31 
LVEF 
[Units: %]
Mean (Standard Deviation)
 31.67  (8.18) 
LVEF 
[Units: %]
Median (Inter-Quartile Range)
 31 
 (25 to 35) 
General cardiovascular history 
[Units: 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 
[Units: Participants]
 
NONE   65 
Ablation   16 
Coronary artery bypass graft (CABG)   11 
Coronary artery intervention   43 
Valve surgery   20 
Other cardiovascular surgery   5 
Previous Device 
[Units: Participants]
 
CRT-D implant   6 
CRT-P implant   39 
ICD implant   1 
IPG implant   37 
other   5 
Atrial Arrhythmia History 
[Units: 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 
[Units: 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 
[Units: 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 


  Outcome Measures
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1.  Primary:   Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.   [ Time Frame: 30 to 120 days ]

2.  Secondary:   Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.   [ Time Frame: 30 to 120 days ]

3.  Secondary:   Evaluation of the Stability of LECG Performance Over Time.   [ Time Frame: 30 to 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of LECG in New Devices Versus Device Replacements.   [ Time Frame: 30 to 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.   [ Time Frame: 30 to 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  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.   [ Time Frame: 30 to 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr Françoise Hidden-Lucet
Organization: Hôpital de la Pitié-Salpêtrière
phone: +33 1 42 16 00 00
e-mail: francoise.hidden-lucet@psl.aphp.fr



Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01297283     History of Changes
Other Study ID Numbers: Leadless ECG Evaluation Study
Study First Received: February 3, 2011
Results First Received: December 23, 2013
Last Updated: February 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: Conseil National de l'Ordre des Médecins