NCT04583709

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

September 29, 2020

Results QC Date

June 22, 2022

Last Update Submit

July 28, 2022

Conditions

BradycardiaHeart Failure

Outcome Measures

Primary Outcomes (5)

  • • 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

  • • 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

  • • 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

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

    LV dispersion measured using ECG Belt

    Visit 1 Baseline- 50 minutes

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

    RV dispersion measured using ECG Belt

    Visit 1 Baseline- 50 minutes

Study Arms (1)

ECG Belt

EXPERIMENTAL

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.

Device: ECG Belt

Interventions

ECG BeltDEVICE

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

ECG Belt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (1)

  • 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.

    PMID: 35907107DERIVED

MeSH Terms

Conditions

BradycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pugazhendhi Vijayaraman
Organization
Geisinger Heart Institute
pvijayaraman1@geisinger.edu
5708085444

Study Officials

  • Pugazhendi Vijayaraman, MD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 12, 2020

Study Start

January 13, 2021

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

August 22, 2022

Results First Posted

August 22, 2022

Record last verified: 2022-07

Locations

US(1)