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Active Not RecruitingNCT06815783

Novel Approach to Conduction System Pacing With Use of Ultrasound

Reduction of Radiation and Improving Conduction System Pacing Using Ultrasound (CONDUCT USe)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
152 (estimated)
Sponsor
Habib Khan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEUltrasound guidanceUse of ultrasound in group 2
DEVICEFluoroscopy guidedConventional techniques for implanting LBBAP lead

Timeline

Start date
2025-04-10
Primary completion
2028-02-28
Completion
2029-02-28
First posted
2025-02-07
Last updated
2025-05-13

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT06815783. Inclusion in this directory is not an endorsement.