Leadless Electrocardiogram (ECG) Evaluation Study

NCT ID: NCT01297283

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Leadless ECG first

Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device

Group Type: EXPERIMENTAL

LECG first

Intervention Type: OTHER

Measurement of the pacing threshold with the support of a leadless ECG

Programmer ECG first

Measurements of pacing thresholds are done first with the support of the programmer ECG

Group Type: ACTIVE_COMPARATOR

Programmer ECG first

Intervention Type: OTHER

Pacing threshold measurements are done with the support of the programmer ECG

Interventions

LECG first

Measurement of the pacing threshold with the support of a leadless ECG

Intervention Type: OTHER

Programmer ECG first

Pacing threshold measurements are done with the support of the programmer ECG

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Françoise HIDDEN-LUCET, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital La Pitié Salpêtrière, Paris, France

Locations

Hôpital La Pitié Salpêtrière

Paris, , France

Countries

France

Other Identifiers

Leadless ECG Evaluation Study

Identifier Type: -

Identifier Source: org_study_id