Left Bundle Branch Area Mapping for Conduction System Pacing

Study Overview
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Brief Summary
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This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.

Detailed Description
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This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.

Official Title
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Left Bundle Branch Area Mapping for Conduction System Pacing

Conditions
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Left Bundle-Branch Block, Pacemaker DDD

Intervention / Treatment
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* Diagnostic Test: 3D Electroanatomical Mapping (NavX)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation. Exclusion Criteria: Recent MI-less than 3 months Recent Percutaneous Coronary Revascularization-less than 2 weeks Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 3D Electroanatomical Mapping (NavX)|To utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. Patients will undergo placement of standard Left Bundle Area pacing leads for routine indications, during the implantation procedure electro-anatomical map of the target area and neighboring tissues will be created. Map characteristics will be analyzed and used intra-operatively to assist with lead placement along with standard pacing metrics and standard X-ray criteria. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroanatomical characteristics of the target area for Left Bundle lead implantation | Electroanatomical metrics | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left bundle branch block, pacemaker, physiologic stimulation