Ultrasound-Guided Pacemaker Implantation for Slow Heart Rate

(RADICAL USE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Habib Khan

Disqualifiers: Bmi >30, Pregnancy, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who need a single-chamber pacemaker or cardioverter-defibrillator. It's not suitable for individuals with a BMI over 30, pregnant women, those needing more complex devices, people with claustrophobia, chest wall issues like trauma or radiation treatment history, active cancer patients, or those with certain implants that interfere with ultrasound.

Inclusion Criteria

I am older than 18 years.

You can have a specific type of heart device called a single chamber pacemaker or single chamber cardioverter-defibrillator.

Exclusion Criteria

You are scared of being in small or enclosed spaces.

I currently have cancer.

I have pain in my chest wall or had an injury there.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo pacemaker implantation using ultrasound and echocardiography, with reduced or conventional fluoroscopy exposure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after pacemaker implantation

4 weeks

Treatment Details

Interventions

• Ultrasound / Echocardiography

Trial Overview The study is testing if using ultrasound instead of radiation can be effective in guiding the implantation of leads into the heart during pacemaker placement. This could potentially reduce risks associated with repeated radiation exposure and allow smaller centers to perform these procedures without expensive X-ray equipment.

Participant Groups

Group I: Reduced fluoroscopy arm Experimental Treatment 1 Intervention

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

Group II: Conventional arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Habib Khan

Lead Sponsor

Trials

4

Recruited

520+