NCT04583709

ECG Belt to Assess Electrical Synchronization

ECG Belt to Assess Electrical Synchronization in Patients With Left Bundle Branch Pacing and His-Purkinje Conduction System Optimized Cardiac Resynchronization Therapy (ECG Belt)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pugazhendhi Vijayaraman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-13
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2020-10-12
• Last updated: 2022-08-22
• Results posted: 2022-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study