Cardiac Resynchronization Therapy
Conditions
Keywords
Electrocardiographic Imaging, Left Bundle Branch Pacing, Cardiac Resynchronization Therapy, Conduction System Pacing
Brief summary
The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.
Interventions
DEVICEECGI system during LBBP implant
ECGI system to create non-invasive ventricular maps during the screwing steps of the LBBP electrode
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Left bundle branch pacing indication * Capability of standing up to place the ECGI vest
Exclusion criteria
* Less than 18 years-old * Patients with cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular resynchronization assessed by ECGI | During procedure | Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VEU | During procedure | Ventricular Electrical Uncoupling computed as the difference between the mean activation time of the left and the right ventricle |
| LVDI | During procedure | Left Ventricle Dyssinchrony Index computed as the standard deviation of individual activations recorded from the left ventricle. |
| Histogram Overlap | During procedure | Overlapping of the right ventricle and left ventricle activation times histogram distributions as a parameter to assess the dyssinchrony between ventricles. |
| LVAT | During procedure | Left Ventricular Activation Time computed as the difference between the earliest and the latest actvation of the left ventricle |
| Isochronal Crowding | During procedure | Number of Isochrones presented in the left ventricular activation map to assess the homogeneity of the activation |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJose Maria Tolosana, MD, PhD
Hospital Clinic of Barcelona
STUDY_DIRECTORMargarida Pujol, MD, PhD
Hospital Clinic of Barcelona
PRINCIPAL_INVESTIGATORLluis Mont Girbau, MD,PhD
Hospital Clinic of Barcelona
Outcome results
None listed