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

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    30
  • sponsor
    SAMBIT MONDAL
Updated on 26 June 2021

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.

Details
Condition Hypertension, Elevated Blood Pressure, high blood pressure, arterial hypertension, heparin-binding protein, heparin binding protein
Clinical Study IdentifierNCT04930601
SponsorSAMBIT MONDAL
Last Modified on26 June 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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