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

HBP Synchrony Using ECG Belt

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04930601

Enrollment

Registered

2021-06-18

Start date

2021-06-01

Completion date

2022-05-01

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBP

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Characterize the electrical dispersion using SDAT	1 year	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.

Countries

United States

Outcome results