The Fluoroless-CSP Trial Using Electroanatomic Mapping

NCT03903107 | Completed

• 1 other identifier: 18090701
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total radiation exposure time during procedure

  Intra-procedure

• Procedure-related complications

  30 days post procedure

• Need for His Lead revisions

  for a period of 6 months post procedure

Study Arms (2)

Conventional Conduction System Pacing(CSP) using fluoroscopy

PLACEBO COMPARATOR

Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.

Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)

Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system

EXPERIMENTAL

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)

Interventions

Conventional fluoroscopy guided Conduction System Pacing(CSP) PROCEDURE

conventional standard approach Conduction System Pacing(CSP) using fluoroscopy

Conventional Conduction System Pacing(CSP) using fluoroscopy

Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) PROCEDURE

Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy

Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 30704289 RESULT

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: April 4, 2019
• Study Start: October 26, 2020
• Primary Completion: April 1, 2021
• Study Completion: September 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)