CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 195 enrolled
Drug / intervention
LECG first +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01297283
NCT01297283N/ACompleted

Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Feb 16, 2011·Updated Jul 18, 2025

In Brief

A clinical study evaluating LECG first and Programmer ECG first for Heart Failure. Completed, enrolled 195 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2011
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.4 years ago

Interventions

LECG firstother

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

Programmer ECG firstother

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