NCT04858698

Brief Summary

Specialized equipment is required to put pacemakers in the heart. This requires use of radiation to see the wires or leads being implanted in the heart. Repeated radiation use can result in permanent injury to the patient and to the doctor. The investigators aim to investigate if they can use ultrasound to guide and help in the implantation of leads into the heart. Ultrasound is a safe method and requires only a small handheld probe and a small screen to see different structures in the heart. If ultrasounds proves successful as a tool to reduce radiation then this would be very useful technical breakthrough. It would help develop smaller centres where pacemakers can be implanted without purchasing xray equipment and expensive setups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

April 8, 2021

Last Update Submit

February 19, 2024

Conditions

BradycardiaBrady-tachy Syndrome

Outcome Measures

Primary Outcomes (1)

  • Success of implanting a single chamber lead with use of ultrasound

    Binary outcome - successful or not.

    0 day

Secondary Outcomes (2)

  • Duration of radiation will be measured in seconds

    during procedure

  • Total radiation dose will be collected in centiGray and milliGray units.

    during procedure

Study Arms (2)

Reduced fluoroscopy arm

EXPERIMENTAL

Patients exposed to 20 seconds or less of fluoroscopy to implant a single chamber device with aid of ultrasound / echocardiography.

Device: Ultrasound / Echocardiography

Conventional arm

ACTIVE COMPARATOR

Patients exposed to more than 20 seconds of fluoroscopy to implant a single chamber device with/without the aid of ultrasound / echocardiography.

Device: Ultrasound / Echocardiography

Interventions

Ultrasound / EchocardiographyDEVICE

Ultrasound will be used to guide vascular access and to place a lead into the right ventricle.

Also known as: Echocardiography by using St Jude - Zonaire ultrasound and P4-1c transducer.
Conventional armReduced fluoroscopy arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old.
  • Suitable to have either a single chamber pacemaker or single chamber cardioverter-defibrillator.

You may not qualify if:

  • BMI \>30.
  • Pregnancy.
  • Implantation of dual-chamber and CRT devices.
  • Claustrophobia.
  • Tender chest wall or history of trauma to the chest wall.
  • Higher signal interference using ultrasound due to the presence of other medical devices or tools used in previous surgical procedures such as sternal wires, mechanical valves, breast implants.
  • History of radiation to the chest wall for oncology treatments.
  • Active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre Res. Inc. (Ont.)

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (1)

  • Khan HR, Triemstra S, Pardo A, Moustafa AT, Mokhtar AT, Antiperovitch P, Saravu S, Mtwesi V, Gula LJ, Leong-Sit P, Manlucu J, Yee R, Tang A. Fluoroless Implantation of Pacemaker and Cardioverter-Defibrillator Using Ultrasound As An Imaging Tool: A Multi-Operator Experience in Radical Use Study. Can J Cardiol. 2025 Dec 23:S0828-282X(25)01596-X. doi: 10.1016/j.cjca.2025.11.052. Online ahead of print.

    PMID: 41448266DERIVED

MeSH Terms

Conditions

Bradycardia

Interventions

UltrasonographyEchocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisCardiac Imaging TechniquesHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor in Cardiology

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 26, 2021

Study Start

July 30, 2021

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)