Recruiting

Observational Study

Sponsor:

Université de Sherbrooke

Code:

NCT04919733

Conditions

Bradycardia

Tachycardia, Ventricular

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fluoroscopy reduction

Study Details

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

Study ID

NCT04919733

Start date

Jan 3, 2020

Status verified date

May, 2022

Completion date

Mar 3, 2024

Anticipated

Primary completion date

Jan 3, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • CIED implants

Exclusion Criteria:

  • 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).

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non fluoroscopy CIED implant

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

Interventions

Fluoroscopy reduction

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

Primary outcome measure

  • Fluoroscopy time needed to implant a CIED while using 3-D mapping systems to reduce fluoroscopy exposure [ Time Frame: During implant procedure ]
  • Peak skin dose of radiation exposure during CIED implant [ Time Frame: During implant procedure ]
  • Radiation exposure (kerma-area product) during CIED implant [ Time Frame: During implant procedure ]
  • Total procedural time [ Time Frame: During implant procedure ]
  • Safety issues arising because of reduction of fluoroscopy [ Time Frame: During implant procedure ]

Central Contacts and Locations

Central contacts

Felix AYALA PAREDES, MD, PhD

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

Claude JEAN, RN

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

Locations

CHUS Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

FELIX AYALA PAREDES, MD PhD

+1 819 3461110felix.ayala-paredes@usherbrooke.ca

Claude JEAN, RN

+1 819 3461110claude.jean.ciussse-chus@ssss.gouv.qc.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 26, 2022

Last verified

May, 2022

Keywords

  • CIED implant
  • Fluoroscopy reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2022-05-26.