ECG Belt to Assess Electrical Synchronization

Not Applicable

Completed

Conditions: Bradycardia
Heart Failure

Interventions: Device: ECG Belt

Registration Number: NCT04583709

Lead Sponsor: Pugazhendhi Vijayaraman

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients > 18 years of age
Patient has a previously implanted LBBP lead for bradycardia indication or heart failure indication with one of the following at Geisinger within the last 5 years:
- LBBP
- LBBP+LV lead
- HBP+LV
Patient is willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

Inability to provide informed consent
Pregnant
Enrolled in a concurrent study that may confound the results of this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECG Belt	ECG Belt	ECG belt will be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using HBP or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on RV pacing and traditional Biventricular pacing.

Primary Outcome Measures

Name	Time	Method
• ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction	Visit 1 Baseline-50 minutes	Change in SDAT following LBBP measured in ms using ECG Belt
• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options	Visit 1 Baseline-50 minutes	Change in QRS duration measured in ms using ECG Belt
• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline	Visit 1 Baseline- 50 minutes	RV dispersion measured using ECG Belt
• ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline	Visit 1 Baseline-50 minutes	Change in LV activation times measured in ms using ECG Belt
• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline	Visit 1 Baseline- 50 minutes	LV dispersion measured using ECG Belt