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Completed

NCT Number: NCT04583709

ECG Belt to Assess Electrical Synchronization

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).

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECG Belt

Device

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

Primary outcomes

  1. • ECG Belt Analysis of Standard Deviation of Activation Times (SDAT) of LBBP Compared to Native Conduction

    Time frame: Visit 1 Baseline-50 minutes

    Change in SDAT following LBBP measured in ms using ECG Belt

  2. • ECG Belt Analysis of Left Ventricular Activations Times (LVAT) of LBBP Compared to Baseline

    Time frame: Visit 1 Baseline-50 minutes

    Change in LV activation times measured in ms using ECG Belt

  3. • ECG Belt Analysis of QRS Duration at Baseline Compared to Various LBBP Options

    Time frame: Visit 1 Baseline-50 minutes

    Change in QRS duration measured in ms using ECG Belt

  4. • ECG Belt Analysis of LV Dispersion of HOT-CRT Compared to Baseline

    Time frame: Visit 1 Baseline- 50 minutes

    LV dispersion measured using ECG Belt

  5. • ECG Belt Analysis of RV Dispersion of HOT-CRT Compared to Baseline

    Time frame: Visit 1 Baseline- 50 minutes

    RV dispersion measured using ECG Belt

Sponsors and collaborators

Lead sponsor

Pugazhendhi Vijayaraman

Other

Collaborators

  • Medtronic

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2020
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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