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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
Use of ultrasound in group 2
Conventional techniques for implanting LBBAP lead
London Health Sciences Centre - University Hospital
London, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Composite of the Following
1. Greater than two attempts at lead deployment to successfully achieve LBBAP 2. Septal perforation 3. Worsening tricuspid regurgitation category 4. Development of LV septal pacing during follow-up
Time frame: During study procedure and through study completion, an average of 12 months
Total Procedure Time
Time frame: During procedure
Total Radiation Dose
Time frame: During procedure
Change of LBBAP pacing parameters
Threshold @ 0.4ms pulse width, sensing, impedance
Time frame: From procedure to 1 week
Change of LBBAP pacing parameters
Threshold @ 0.4ms pulse width, sensing, impedance
Time frame: From procedure to 1 year
Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec)
Time frame: Through study completion, an average of 12 months
LVEF Improvement
Time frame: From baseline to 12 months
Patient Satisfaction
Time frame: Through study completion, an average of 12 months
Differences in Quality of Life - EQ5D
Time frame: From baseline to 12 months
Amount of Tricuspid Regurgitation
Measured in mmHg
Time frame: Through study completion during echocardiography studies, an average of 12 months
Change in NTproBNP
Time frame: From baseline to 12 months
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