Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block (MAP HIS HF)

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    30
  • sponsor
    Abbott Medical Devices
Updated on 20 April 2022
heart failure
left bundle branch block

Summary

This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.

Details
Condition Heart Failure, Left Bundle-Branch Block
Treatment Mapping and Pacing the His Bundle, Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
Clinical Study IdentifierNCT03803995
SponsorAbbott Medical Devices
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
An ECG with a wide QRS complex (>130 ms)
ECG morphology of typical complete LBBB
Patients have heart failure with NYHA Class II-IV symptoms
LV EF <50%
At least 18 years old and not pregnant
Must provide written informed consent prior to any clinical investigation related procedure
Willing to comply with study evaluation requirements
Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)

Exclusion Criteria

Patients have non-specific intraventricular conduction delay or right bundle branch block
Previously implanted cardiac devices with three or more permanent leads
History of aortic valve repair or replacement
History of tricuspid valve replacement
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
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