The Fluoroless-CSP Trial Using Electroanatomic Mapping

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure, Systolic; Sinus Node Dysfunction; Heart Block AV; LBBB
• Intervention / Treatment: Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP); Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional Conduction System Pacing(CSP) using fluoroscopy; Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.	Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP); conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
Experimental: Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system; 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); Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Publications and helpful links

General Publications

• Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006967.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Failure; Heart Block; Heart Failure, Systolic; Sick Sinus Syndrome
• Other Study ID Numbers: 18090701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No