Reduction of radiation and improving conduction system pacing using ultrasound (CONDUCT USe)
CONDUCT USe
Lead PI & Sponsor
Dr. Habib Khan
Local PI
Dr. Habib Khan
Research Staff
Sara El-Richani & Megan Smith
Objective
The objective of the CONDUCT-Use study is to evaluate the efficacy of ultrasound delivery of pacing leads to the particular region of LBBA deep into the septum. LBBA recruitment will be measured using internationally standardized criterion. It is hypothesized that the use of ultrasound alongside fluoroscopy during the implantation of LBBAP leads will decrease the number of attempts needed and increase safety by reducing occurrence of septal perforation, cardiac tamponade, lead dislodgement, and lead revisions. Additionally, procedure time and radiation exposure will be minimized, providing an advantage to both patients and operators.
Target Number of Patients
152
Currently Enrolled
0
Primary Outcomes
- Greater than two attempts at lead deployment to successfully achieve LBBAP
- Septal perforation
- Worsening tricuspid regurgitation category
- Development of LV septal pacing during follow-up
Inclusion Criteria
- Male or female age > 18 years
- Eligible to have a single or dual chamber pacemaker implanted for LBBAP
- Confirmed diagnosis of conduction tissue disease
- The participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements
- Good imaging quality determined on routine echocardiography
Exclusion Criteria
- Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant’s ability to participate in the study
- Any acute active malignancy requiring treatment or life expectancy is deemed less than 1 year
- Clinically significant disease that increases risk of bleeding (hematological disorders, dialysis patient – anticoagulation does not apply)
- History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation
- Hepatic impairment defined as ALT/AST >3 × ULN and/or total bilirubin >ULN, at screening
- The participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation
- Any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation
- CRT and ICD implants
- Pregnancy or female of childbearing age (if negative pregnancy test not provided)
Each year, over one million pacemakers (a device that paces the heart) 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
ventricles 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.