ECG Belt to Assess Electrical Synchronization

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583709
• Other study ID #: 2020-0465
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: June 25, 2021

Study information

• Verified date: July 2022
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Device:
• ECG Belt
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

Locations

Country	Name	City	State
United States	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pugazhendhi Vijayaraman	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	Visit 1 Baseline-50 minutes
Primary	• 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	Visit 1 Baseline-50 minutes
Primary	• ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options	Change in QRS duration measured in ms using ECG Belt	Visit 1 Baseline-50 minutes
Primary	• ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline	LV dispersion measured using ECG Belt	Visit 1 Baseline- 50 minutes
Primary	• ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline	RV dispersion measured using ECG Belt	Visit 1 Baseline- 50 minutes