Using ultrasound to reduce radiation during pacemaker implantation

Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound (RADICAl USe)

This study is testing whether using ultrasound instead of x-rays during pacemaker implantation can make the procedure safer for patients and doctors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT04858698 on ClinicalTrials.gov

What this trial studies

This study investigates the use of ultrasound as a guiding tool for the implantation of cardiac devices, specifically pacemakers, to minimize or eliminate the need for radiation. The approach aims to enhance safety for both patients and healthcare providers by utilizing a handheld ultrasound probe instead of traditional x-ray equipment. The study will assess the effectiveness of ultrasound in visualizing leads during the procedure, potentially making pacemaker implantation more accessible in smaller medical centers. By leveraging advancements in imaging technology, the study seeks to establish a safer and cost-effective method for cardiac device implantation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who require a single chamber pacemaker or cardioverter-defibrillator.

Not a fit: Patients with a BMI over 30, those who are pregnant, or individuals requiring dual-chamber or CRT devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce radiation exposure for patients and healthcare providers during pacemaker implantation.

How similar studies have performed: While there have been experimental studies using ultrasound for similar purposes, this specific approach is novel and has not been widely tested in clinical settings.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. BMI \>30.
2. Pregnancy.
3. Implantation of dual-chamber and CRT devices.
4. Claustrophobia.
5. Tender chest wall or history of trauma to the chest wall.
6. 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.
7. History of radiation to the chest wall for oncology treatments.
8. Active malignancy

Where this trial is running

London, Ontario

• London Health Sciences Centre Res. Inc. (Ont.) — London, Ontario, Canada (Recruiting)

Conditions Bradycardia; Brady-tachy Syndrome