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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapping and Pacing the His Bundle | Other | All patients will be in this arm. Mapping and Pacing the His Bundle will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapping and Pacing the His Bundle | Procedure | During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSiteâ„¢ Precisionâ„¢ mapping system and Advisorâ„¢ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
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| Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing | Procedure | 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. |
|
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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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