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Completed

NCT Number: NCT03903107

The Fluoroless-CSP Trial Using Electroanatomic Mapping

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.

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Key information

Conditions

Sinus Node Dysfunction Arrhythmia, Sinus Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Block AV Heart Diseases Heart Failure Heart Failure, Systolic LBBB Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional fluoroscopy guided Conduction System Pacing(CSP)

Procedure

conventional standard approach 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

Primary outcomes

  1. Success of achieving CSP

    Time frame: 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 outcomes

  1. Total radiation exposure time during procedure

    Time frame: 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.

  2. Procedure-related complications

    Time frame: 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.

  3. Need for His Lead revisions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Apr 4, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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