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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ultrasound, a safe imaging technique, can guide the implantation of pacemakers while minimizing radiation use. Pacemakers manage slow heart rates. The trial aims to determine if ultrasound can reduce radiation exposure, which may cause harm over time. This trial may suit individuals needing a single-chamber pacemaker or cardioverter-defibrillator who are not significantly overweight. As an unphased study, it offers a unique opportunity to contribute to innovative research that could enhance future pacemaker implantation procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ultrasound-guided pacemaker implantation is safe?

Research has shown that using ultrasound to guide pacemaker placement is generally safe for patients. Studies have found this method to have a high success rate with few side effects. For instance, one study used only ultrasound to insert a pacemaker without any major problems.

Ultrasound is often used in medical procedures because it is non-invasive and does not involve radiation, making it safer than traditional methods that use X-rays.

Overall, evidence suggests that ultrasound-guided pacemaker placement is well-tolerated and carries a low risk of side effects. This could make it an appealing choice for those considering this method for pacemaker placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasound-guided pacemaker implantation for slow heart rate because it offers a significant reduction in radiation exposure compared to conventional methods. Traditional pacemaker implantation often relies on fluoroscopy, exposing patients to longer periods of radiation. This new technique uses ultrasound and echocardiography to potentially limit fluoroscopy exposure to just 20 seconds or less, making the procedure safer. Additionally, reducing radiation can decrease the risk of related complications, which is a significant advancement in the treatment of slow heart rate.

What evidence suggests that ultrasound is effective for guiding pacemaker implantation?

Research has shown that using ultrasound to assist in pacemaker placement can be highly effective. In one study, doctors successfully placed pacemaker leads with ultrasound guidance every time, eliminating the need for traditional radiation. This trial will compare two approaches: the reduced fluoroscopy arm, where patients receive 20 seconds or less of fluoroscopy with ultrasound assistance, and the conventional arm, where patients receive more than 20 seconds of fluoroscopy with or without ultrasound. These early successes suggest that ultrasound may reduce radiation exposure, enhancing safety for both patients and doctors. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-bradycardia-6-2021-9b1e5

Ultrasound-Guided Pacemaker Implantation for Slow Heart ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475883/

Ultrasound‐guided pacemaker implantation at the bedside The success rates of venipuncture and temporary pacemaker electrode placement were both 100% in the bedside ultrasound‐guided installation group ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352906725001708

Comparison of clinical outcomes between catheter ablation ... Comparison of clinical outcomes between catheter ablation and permanent pacemaker implantation in Tachycardia-Bradycardia Syndrome patients: a meta-analysis.

4. jacc.org jacc.org/doi/10.1016/j.jaccas.2022.05.034

A First-in-Human Complete Insertion of Single-Chamber ... We report a first-in-human case report of successful pacemaker insertion performed entirely with ultrasound.

5. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(23)00139-9/fulltext

A cost-effectiveness analysis of remote monitoring after ... Although remote monitoring (RM) after pacemaker implantation is common, its cost-effectiveness has not been fully investigated.

6. nature.com nature.com/articles/s41598-024-69388-2

Feasibility, safety and outcomes of conduction system ... CSP improves clinical outcomes in all age-groups, without compromising procedural safety or pacemaker performance in the very elderly.