Conduction Block, Atrioventricular, Bundle-Branch Block
Conditions
Keywords
Conduction system pacing, Left bundle branch area pacing, HIS bundle pacing, pacemaker, ultrasound, NTproBNP, EQ5D, LVEF
Brief 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.
Interventions
DEVICEUltrasound guidance
Use of ultrasound in group 2
DEVICEFluoroscopy guided
Conventional techniques for implanting LBBAP lead
Sponsors
Academic Medical Organization of Southwestern Ontario
Habib Khan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting the following criteria are eligible for the study: 1. Male or female ≥18 years of age 2. Eligible to have a single or dual chamber pacemaker implanted for LBBAP 3. Confirmed diagnosis of conduction tissue disease 4. The participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements. 5. Good imaging quality determined on routine echocardiography
Exclusion criteria
Patients will be excluded if any one of the following criteria is met: 1. Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study. 2. Any acute active malignancy requiring treatment or life expectancy is deemed less than 1 year. 3. Clinically significant disease that increases their risk of bleeding (hematological disorders, dialysis patient - anticoagulation does not apply) 4. History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation. 5. Hepatic impairment defined as ALT/AST \>3 × ULN and/or total bilirubin \>ULN, at Screening. 6. The participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation 7. Any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation. 8. CRT and ICD implants. 9. Pregnancy or female of childbearing age (if negative pregnancy test not provided).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of the Following | During study procedure and through study completion, an average of 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Radiation Dose | During procedure | — |
| Change of LBBAP pacing parameters | From procedure to 1 week | Threshold @ 0.4ms pulse width, sensing, impedance |
| 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 | — |
| Total Procedure Time | During procedure | — |
| Differences in Quality of Life - EQ5D | From baseline to 12 months | — |
| Amount of Tricuspid Regurgitation | Through study completion during echocardiography studies, an average of 12 months | Measured in mmHg |
| Change in NTproBNP | From baseline to 12 months | — |
| Patient Satisfaction | Through study completion, an average of 12 months | — |
Countries
Canada
Outcome results
None listed