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Device

3-D Mapping Systems for Heart Rhythm Disorders

N/A
Waitlist Available
Led By Felix AYALA PAREDES, MD, PhD
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during implant procedure
Awards & highlights

Study Summary

This trial will test how effective 3-D mapping systems are in reducing fluoroscopy times during CIED implants.

Who is the study for?
This trial is for patients who need a CIED implant, which helps manage heart conditions like rapid or slow heartbeat and heart failure. It's not for those with urgent life-threatening situations requiring immediate CIED implants or known issues with their venous system.Check my eligibility
What is being tested?
The study is testing if using a 3-D mapping system can significantly reduce or even eliminate the use of fluoroscopy (a type of X-ray) during the procedure to place a CIED implant in patients.See study design
What are the potential side effects?
Since this trial focuses on reducing fluoroscopy exposure, potential side effects may include less radiation-related risks compared to standard procedures. Specific side effects will depend on individual patient responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during implant procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during implant procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure
Peak skin dose of radiation exposure during CIED implant
Radiation exposure (kerma-area product) during CIED implant
+2 more
Secondary outcome measures
Current of lesion at desired implant fixation site (Y/N)
Detailed 3-D mapping needed Y/N

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non fluoroscopy CIED implantExperimental Treatment1 Intervention
Try to reduce as much as possible the fluoroscopy needed to implant a CIED pacemaker or defibrillator using a 3-D mapping system

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
298 Previous Clinical Trials
69,785 Total Patients Enrolled
Felix AYALA PAREDES, MD, PhDPrincipal InvestigatorUniversity of Shebrooke Medical School

Media Library

Fluoroscopy reduction (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04919733 — N/A
Slow Heart Rate Research Study Groups: Non fluoroscopy CIED implant
Slow Heart Rate Clinical Trial 2023: Fluoroscopy reduction Highlights & Side Effects. Trial Name: NCT04919733 — N/A
Fluoroscopy reduction (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04919733 — N/A
~28 spots leftby Jun 2025
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