HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System

HBP Synchrony Using ECG Belt

The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.

Study Overview

• Status: Recruiting
• Conditions: HBP

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Recruiting
      • Orlando Cardiac & Vascular Specialists
      • Contact: Sambit Mondal, MD; Phone Number: 407-915-5643; Email: sambitmondal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target population will include subjects with normal EF who have a Medtronic device and a HIS placed RV lead. In addition, we will include subjects who have intact AV conduction.

Description

Inclusion Criteria:

• Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead
• Patient has intrinsic AV conduction
• Normal EF, defined as EF >50%, as shown on recent echo within last 12 months
• Patient is willing and able to comply with the protocol
• Patient is 18 years of age or older

Exclusion Criteria:

●Patient is ventricular pacer dependent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the electrical dispersion using SDAT	Characterize the electrical dispersion between intrinsic to both Selective HIS pacing and Non-Selective HIS pacing using Standard Deviation Activation Timing of the ECG Belt system.	1 year

Collaborators and Investigators

• Sponsor: SAMBIT MONDAL

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OSCMondal062021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No