At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Leadless ECG Evaluation Study - Prospectively, Randomized, Cross-over, Multi-center, Interventional, Post-market Release Study to Evaluate the LECG System.
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
Timeline
Interventions
Measurement of the pacing threshold with the support of a leadless ECG
Pacing threshold measurements are done with the support of the programmer ECG