MedTrace Logo

The Fluoroless-CSP Trial Using Electroanatomic Mapping

NCT03903107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-02-28

No results posted yet for this study

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

Interventions

PROCEDURE

Conventional fluoroscopy guided Conduction System Pacing(CSP)

conventional standard approach Conduction System Pacing(CSP) using fluoroscopy

PROCEDURE

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

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2021-04-01
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03903107 on ClinicalTrials.gov