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โ† Trials
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Novel Approach to Conduction System Pacing With Use of Ultrasound

RecruitingNAAges 18 Years - anyAllHabib Khan
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: Patients meeting the following criteria are eligible for the study: 1. Male or female โ‰ฅ18 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 ร— 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).
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What it tests

  • Ultrasound guidance
  • Fluoroscopy guided
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Where

2 sites
London Health Sciences Centre - University Hospital
London, Canada
London Health Sciences Centre
London, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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