Clinical trial NCT01297283: Leadless Electrocardiogram (ECG) Evaluation Study
Official title: Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Cardiac resynchronization
Leadless ECG
Follow-up
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.
timeFrame: 30 to 120 days
Secondary outcomes:
measure: Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.
timeFrame: 30 to 120 days
measure: Evaluation of the Stability of LECG Performance Over Time.
timeFrame: 30 to 120 days
measure: Quality of LECG in New Devices Versus Device Replacements.
timeFrame: 30 to 120 days
measure: Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.
timeFrame: 30 to 120 days
measure: 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.
timeFrame: 30 to 120 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
Study officials:
affiliation: Hôpital La Pitié Salpêtrière, Paris, France
name: Françoise HIDDEN-LUCET, MD
role: PRINCIPAL_INVESTIGATOR
References: