The Fluoroless-CSP Trial Using Electroanatomic Mapping

Not Applicable

Completed

• Conditions: Sinus Node Dysfunction; Heart Block AV; Heart Failure, Systolic; LBBB
• Interventions: Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP); Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)

• Registration Number: NCT03903107
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Study Start: 2020-10-26
• Primary Completion: 2021-04-01
• Study Completion: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system	Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)	Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.
Conventional Conduction System Pacing(CSP) using fluoroscopy	Conventional fluoroscopy guided Conduction System Pacing(CSP)	Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.

Primary Outcome Measures

Name	Time	Method
Success of achieving CSP	Intra-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedure-related complications	30 days post procedure	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.
Total radiation exposure time during procedure	Intra-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.
Need for His Lead revisions	for a period of 6 months post procedure	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States