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| Name | Class |
|---|---|
| Academic Medical Organization of Southwestern Ontario | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure. |
|
| US guided | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guidance | Device | Use of ultrasound in group 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of the Following |
| During study procedure and through study completion, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | During procedure | |
| Total Radiation Dose | During procedure | |
| Change of LBBAP pacing parameters |
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Inclusion criteria: Patients meeting the following criteria are eligible for the study:
Exclusion Criteria: Patients will be excluded if any one of the following criteria is met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre - University Hospital | London | Ontario | N6A5A5 | Canada | ||
| London Health Sciences Centre |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Physicians making the referral for pacing or seeing patients in the future will be masked to whether the patients had ultrasound-guided left bundle branch area pacing. The outcomes assessor will not be aware of whether the patients will be randomized to Group 1 (conventional use of fluoroscopy) or Group 2 (assisted with ultrasound)
| Fluoroscopy guided |
| Device |
Conventional techniques for implanting LBBAP lead |
|
Threshold @ 0.4ms pulse width, sensing, impedance |
| From procedure to 1 week |
| Change of LBBAP pacing parameters | Threshold @ 0.4ms pulse width, sensing, impedance | From procedure to 1 year |
| Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec) | Through study completion, an average of 12 months |
| LVEF Improvement | From baseline to 12 months |
| Patient Satisfaction | Through study completion, an average of 12 months |
| Differences in Quality of Life - EQ5D | From baseline to 12 months |
| Amount of Tricuspid Regurgitation | Measured in mmHg | Through study completion during echocardiography studies, an average of 12 months |
| Change in NTproBNP | From baseline to 12 months |
| London |
| Ontario |
| N6G5A5 |
| Canada |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |