N/A
N=195
Leadless Electrocardiogram (ECG) Evaluation Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01297283 ↗Enrolled (actual)
195
Serious AEs
18.0%
Results posted
Apr 2014
Primary outcome: Primary: Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. — 0.99; 0.98; 0.98; 0.96 proportion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LECG first (Other); Programmer ECG first (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure. |
0.99; 0.98; 0.98; 0.96 | — |
| SECONDARY Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer. |
0.51 | — |
| SECONDARY Evaluation of the Stability of LECG Performance Over Time. |
— | — |
| SECONDARY Quality of LECG in New Devices Versus Device Replacements. |
— | — |
| SECONDARY Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality. |
— | — |
| 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. |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01297283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.