The Fluoroless-CSP Trial Using Electroanatomic Mapping

Study Overview
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Brief Summary
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The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

Detailed Description
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The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants. In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.

Official Title
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Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial

Conditions
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Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic

Intervention / Treatment
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* Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)
* Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device Exclusion Criteria: Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity Pregnancy Difficulty with follow-up

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional Conduction System Pacing(CSP) using fluoroscopy<br>Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique. | Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)<br>* conventional standard approach Conduction System Pacing(CSP) using fluoroscopy<br>|
| Experimental: Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system<br>Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure. | Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)<br>* Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of achieving CSP | Feasibility of achieving a successful CSP implant at the His Bundle or Left Bundle branch with low or zero Fluoroscopy. This will result in low to no fluoroscopy exposure for both the subject and the operator, as well as shorter procedure times.This will be documented during procedure. | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiation exposure time during procedure | Total radiation exposure during procedure time will be documented at the total time the patient is exposed to fluoroscopy during the procedure. This will will be tracked and documented as total fluoroscopy duration, His lead Fluoroscopy duration and DAP. The total amounts of procedural fluoroscopy exposure will be compared between the two treatment arms. | Intra-procedure | 
| Procedure-related complications | The study team will review medical history of enrolled subjects for any adverse event experienced post-procedurally. All adverse events will be reviewed by PI for determination as to whether procedure-related or not. | 30 days post procedure | 
| Need for His Lead revisions | The study team will track the device follow-up data for a duration of 3 months post device implant. Any patients with > 2V increase in His Lead capture threshold from baseline and need for ventricular pacing will undergo a lead revision. | for a period of 6 months post procedure |