Ultrasound Guidance for Heart Block
(CONDUCT USe Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Habib Khan

No Placebo Group

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.

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

I am 18 years old or older.

Good imaging quality determined on routine echocardiography

+2 more

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

+6 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: US guidedExperimental Treatment1 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: ConventionalActive Control1 Intervention

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