Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block

Phase

N/A

Condition

Hyponatremia

Arrhythmia

Heart Defect

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 ID

NCT03803995

CRD 969

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients are undergoing implant of an Abbott pacemaker or CRT device under standardindications
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 relatedprocedure.
Willing to comply with study evaluation requirements
Female subjects of child-bearing potential are required to have a negative pregnancytest done within 7 days prior to the implant procedure per site standard test.Female patients of childbearing potential should be instructed to use safecontraception (e.g., intrauterine devices, hormonal contraceptives: contraceptivepills, implants, transdermal patches hormonal vaginal devices, injections withprolonged release.)

Exclusion

Exclusion Criteria:

Patients have non-specific intraventricular conduction delay or right bundle branchblock
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 clinicalinvestigation follow-up period.
Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or anycondition within the last 90 days that would contraindicate for pacemaker or CRTimplant in the opinion of the investigator
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.

Study Design