Ultrasound Guidance for Heart Block

(CONDUCT USe Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Habib Khan

Disqualifiers: Malignancy, Bleeding disorders, Hepatic impairment, others

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

Compensation: Varies

Number of Visits: 1

152 Participants Needed

Trial Summary

What is the purpose of this trial?

Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have been aimed at determining which area of the heart is the best option for lead placement. An area in the septum separating the verticals called the left bundle branch area (LBBA) has previously been identified as a safe and effective area for lead placement. However, as the LBBA location is in the center of the heart, it is impossible to see the entire extent using X-ray. Current practice requires x-ray guidance to estimate the location and pacing parameters to confirm proximity. Implanting in LBBA takes longer procedure times and higher exposure to X-ray radiation for both patients and hospital staff. Over time, radiation poses an increased risk of cancer and other medical issues. This study will determine if using ultrasound can improve pacemaker lead implantation to the LBBA. Benefits to patients may include fewer attempts and more accuracy in lead deployment, thereby reducing risks and providing improved outcomes. Benefits to healthcare delivery may include reduction in total procedure time, thereby allowing more cases per day to reduce waitlist, and reduced X-ray exposure to staff thereby reducing cumulative effects.

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 coordinator or your doctor.

What data supports the effectiveness of the treatment Novel Approach to Conduction System Pacing with Use of Ultrasound?

Research shows that using ultrasound for cardiac pacing, which avoids traditional pacing leads, has been demonstrated in both animals and humans, suggesting it could reduce complications associated with leads and improve the choice of stimulation site. Additionally, pacing the heart's conduction system can prevent or reverse heart desynchronization, which is beneficial for patients with certain heart conditions. ^{1 2 3 4 5}

Is ultrasound-guided heart block treatment safe for humans?

Research shows that using ultrasound for heart pacing is generally safe in humans, with energy levels within safety limits set by international organizations. This method avoids complications associated with traditional pacing leads. ^{1 4 6 7 8}

How is the ultrasound guidance treatment for heart block different from other treatments?

This treatment is unique because it uses ultrasound to stimulate the heart without needing a pacing lead, which is a wire used in traditional pacemakers. This approach reduces complications associated with leads and allows for more precise targeting of the heart's stimulation site. ^{1 4 9 10 11}

Eligibility Criteria

This trial is for patients with various types of heart block, such as Bundle-Branch Block and Atrioventricular Block. It's specifically looking at those who need pacemaker lead placement in the left bundle branch area (LBBA) of the heart. The study aims to include individuals who can benefit from a potentially safer and more accurate implantation method using ultrasound instead of X-rays.

Inclusion Criteria

The participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements

Good imaging quality determined on routine echocardiography

I am eligible for a pacemaker implant for left bundle branch area pacing.

Exclusion Criteria

CRT and ICD implants

Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study

History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo pacemaker lead implantation using either ultrasound guidance or conventional x-ray methods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of tricuspid regurgitation and pacing parameters

12 months

Regular visits (in-person and virtual)

Treatment Details

Interventions

• Novel Approach to Conduction System Pacing with Use of Ultrasound

Trial Overview The trial is testing whether using ultrasound guidance for pacemaker lead implantation into the LBBA is better than the traditional fluoroscopy (X-ray) guided method. It seeks to determine if ultrasound can reduce procedure time, improve accuracy, decrease radiation exposure, and ultimately provide better patient outcomes.

Participant Groups

Group I: US guided Experimental Treatment 1 Intervention

Patients randomized to this arm will have use of ultrasound in venous access and particularly in attempts to place the pacing lead in the septum at the region of LBBA. This will allow the lead to be directly visualized as it is being passed deep into the septum without perforation and it ensure that the lead is perpendicular to the septum.

Group II: Conventional Active Control 1 Intervention

Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure.

Who Is Running the Clinical Trial?

Habib Khan

Lead Sponsor

Trials

4

Recruited

520+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

References

1. England pubmed.ncbi.nlm.nih.gov

In the wireless era: leadless pacing. [2010]

2. Poland pubmed.ncbi.nlm.nih.gov

[Diagnostic value and safety of stress echocardiography protocol based on rapid pacing in patients with implanted pacemakers]. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

[His bundle and left bundle branch pacing]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

First human demonstration of cardiac stimulation with transcutaneous ultrasound energy delivery: implications for wireless pacing with implantable devices. [2007]

5. France pubmed.ncbi.nlm.nih.gov

[Resynchronization of the failing heart by pacing]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Maintaining physiological pacing in AV block using a new generation single lead VDD pacemaker. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Conduction system pacing: overview, definitions, and nomenclature. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Properties of ultrasonically marked leads. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The potential of ultrasound in cardiac pacing and rhythm modulation. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Extracorporeal acute cardiac pacing by high intensity focused ultrasound. [2014]

11. United States pubmed.ncbi.nlm.nih.gov

Ultrasonic cardiac pacing in the porcine model. [2009]