Clinical trial NCT04583709: ECG Belt to Assess Electrical Synchronization
Official title: ECG Belt to Assess Electrical Synchronization in Patients With Left Bundle Branch Pacing and His-Purkinje Conduction System Optimized Cardiac Resynchronization Therapy (ECG Belt)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Heart Failure
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years of age
2. 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
3. Patient is willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

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

Primary outcomes:
measure: • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction
timeFrame: Visit 1 Baseline-50 minutes
measure: • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline
timeFrame: Visit 1 Baseline-50 minutes
measure: • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options
timeFrame: Visit 1 Baseline-50 minutes
measure: • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline
timeFrame: Visit 1 Baseline- 50 minutes
measure: • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline
timeFrame: Visit 1 Baseline- 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Pugazhendi Vijayaraman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vijayaraman P, Hughes G, Manganiello M, Johns A, Ghosh S. Non-invasive assessment of ventricular electrical heterogeneity to optimize left bundle branch area pacing. J Interv Card Electrophysiol. 2023 Aug;66(5):1103-1112. doi: 10.1007/s10840-022-01315-9. Epub 2022 Jul 30.