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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure, Left Bundle-Branch Block

Intervention / Treatment
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* Procedure: Mapping and Pacing the His Bundle
* Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mapping and Pacing the His Bundle<br>All patients will be in this arm. Mapping and Pacing the His Bundle will be performed. | Procedure: Mapping and Pacing the His Bundle<br>* During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.<br>Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing<br>* During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful HB pacing sites | Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure. | At device implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of HB pacing | Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure; | At device implant procedure | 
| Ventricular activation during HB pacing | Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure; | At device implant procedure | 
| Echocardiographic measurements of LV ejection fraction | Collect echo measurements of LV ejection fraction at three-month follow-up visit | At three-month follow-up | 
| Echocardiographic measurements of LV end-systolic volume | Collect echo measurements of LV end-systolic volume at three-month follow-up visit | At three-month follow-up | 
| Capture threshold of HB pacing | Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant | Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit | 
| Lead impedance of HB pacing lead | Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant | Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit | 
| Sensing amplitude of HB pacing lead | Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant | Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit |