Fluoroscopy Reduction or Elimination in CIED Implants

NCT04919733 | Unknown

• 1 other identifier: 2019-3060
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

CIED implants require different amounts of fluoroscopy; using 3-D mapping systems, these times could be reduced to near zero fluoroscopy. The investigators aim to describe to what extent fluoroscopy times are reduced on a routine basis on CIED implants

Conditions

Bradycardia; Tachycardia, Ventricular; Heart Failure

Keywords

CIED implant; Fluoroscopy reduction

Outcome Measures

Primary Outcomes (5)

• Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure

  Fluoroscopy time while implanting a CIED

  During implant procedure

• Peak skin dose of radiation exposure during CIED implant

  Radiation exposure expressed as total Cumulative Air Kerma (mGy)

  During implant procedure

• Radiation exposure (kerma-area product) during CIED implant

  Total Dose Area Product (uGy-m2)

  During implant procedure

• Total procedural time

  Time of the patient entering the lab, to the time the patient exits the lab

  During implant procedure

• Safety issues arising because of reduction of fluoroscopy

  Complications arising while using a reduced fluoroscopy environment

  During implant procedure

Secondary Outcomes (2)

• Detailed 3-D mapping needed Y/N

  During implant procedure

• Current of lesion at desired implant fixation site (Y/N)

  During implant procedure

Study Arms (1)

Non fluoroscopy CIED implant

EXPERIMENTAL

Try to reduce as much as possible the fluoroscopy needed to implant a CIED pacemaker or defibrillator using a 3-D mapping system

Device: Fluoroscopy reduction

Interventions

Fluoroscopy reduction DEVICE

To decrease, using 3-D mapping systems, the amount of fluoroscopy needed to implant a CIED

Non fluoroscopy CIED implant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CIED implants

You may not qualify if:

• Patients with an urgent life-threatening indication requiring an urgent CIED implant.
• Patients with known venous system abnormalities (as venous occlusion or abandoned non-accessible leads).

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Bradycardia; Tachycardia, Ventricular; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Felix AYALA PAREDES, MD, PhD

  University of Shebrooke Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix AYALA PAREDES, MD, PhD

CONTACT

819 346 1110; felix.ayala-paredes@usherbrooke.ca

Claude JEAN, RN

CONTACT

819 346 1110; claude.jean.ciussse-chus@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To ascertain if the use of 3-D mapping systems reduces the need of fluoroscopy during a CIED (pacemaker or defibrillator) implant

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 9, 2021
• Study Start: January 3, 2020
• Primary Completion: January 3, 2024
• Study Completion: March 3, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)