The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare with preexisting data in traditional Cardiac Resynchronization Therapy (CRT) and Right Ventricular Pacing (RVP).
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of LBBP and HOT-CRT and compare with preexisting data in traditional CRT and RVP. Specific Objective: * To demonstrate and establish electrical resynchronization using ECG Belt Research System in Left Bundle Branch Pacing (LBBP) and HOT-CRT. * To assess ECG Belt derived native conduction parameters and compare them to LBBP and HOT-CRT. * To compare with historic ECG belt parameters obtained for right ventricular pacing/ Biventricular pacing in prior studies. The ECG Belt study is a prospective, single-center, investigational, pre-market research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the ECG Belt Research System to assess the electrical characteristics of conduction system pacing in patients with preexisting LBBP or HOT-CRT. Eligible patients would have successfully undergone LBBP using Medtronic 3830 lead. LBBP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak LV activation time and lead depth in the LV septum by contrast at implant and 2D echo post-implant. ECG belt would be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using His-Bundle Pacing (HBP) or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on Right Ventricular RV pacing and traditional Biventricular pacing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
ECG Belt Research System Procedure LBBP Native conduction RV pacing if available Bipolar LBBP Unipolar LBBP - nonselective and selective (different outputs) Fusion pacing with native conduction at different Atrioventricular (AV) delays HOT-CRT Native conduction HBP / LBBP HOT-CRT AV delay optimization. Medtronic Device (pacemaker/ICD) based Holter recording during the ECG belt recording
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
Change in SDAT following LBBP measured in ms using ECG Belt
Time frame: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline
Change in LV activation times measured in ms using ECG Belt
Time frame: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
Change in QRS duration measured in ms using ECG Belt
Time frame: Visit 1 Baseline-50 minutes
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
LV dispersion measured using ECG Belt
Time frame: Visit 1 Baseline- 50 minutes
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
RV dispersion measured using ECG Belt
Time frame: Visit 1 Baseline- 50 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.