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Pacing
Left Bundle Branch vs Right Ventricular Pacing for Heart Block
N/A
Recruiting
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including:
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at 1, 12, and 24 months, measure as compared to baseline
Awards & highlights
Study Summary
This trial found that LBBP may help avoid some of the negative consequences of RV pacing.
Who is the study for?
This trial is for adults over 18 with certain types of heart block who need a lot of ventricular pacing and have an ejection fraction over 35%. It's not for those needing a defibrillator, with mechanical tricuspid valves, previous similar device attempts, pregnant women, permanent atrial fibrillation patients or those with short life expectancy.Check my eligibility
What is being tested?
The study compares two pacemaker leads: one that paces the left bundle branch (mimicking natural heart rhythm) versus standard right ventricular pacing. The goal is to see if the new method can reduce negative effects on heart function caused by traditional pacing.See study design
What are the potential side effects?
Potential side effects may include complications from implanting the device such as bleeding or infection at the site, lead dislodgement, and in rare cases damage to nearby structures like nerves or blood vessels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a pacemaker and have a severe heart block.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at 1, 12, and 24 months, measure as compared to baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at 1, 12, and 24 months, measure as compared to baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to cardiovascular death
Time to first heart failure event
Worsening LV end systolic vloume index at 2 years
Secondary outcome measures
Atrial fibrillation progression
Cardiovascular mortality
Change in Lead parameter
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: left bundle branch pacingExperimental Treatment1 Intervention
Group II: Right ventricular pacingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Left bundle branch pacing lead (Select Secure 3830 lead)
2021
N/A
~40
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,452,267 Total Patients Enrolled
1 Trials studying Heart Block
120 Patients Enrolled for Heart Block
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
158,426 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
70,810 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tricuspid valve that was replaced with a mechanical one.You need an implantable device to help with heart rhythm problems.I have permanent atrial fibrillation.I need a pacemaker and have a severe heart block.Your heart's ejection fraction is more than 35%.You have a specific type of heart block called third degree AV block.My heart's electrical system problem is expected to improve.I am 18 years old or older.I am unable to understand or make decisions about my treatment.You have a specific type of heart rhythm problem called second-degree AV block.I do not have a serious illness that would limit my life to less than 2 years.You have a specific type of heart condition called first degree AV block with certain measurements.You have had a heart ultrasound in the past 3 months, and can provide the image files.You have previously tried to have a certain type of heart device implanted.
Research Study Groups:
This trial has the following groups:- Group 1: Right ventricular pacing
- Group 2: left bundle branch pacing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary goals of this medical experiment?
"Spanning around a month, this clinical trial aims to assess the success rate of recruitment. Secondary objectives include observing changes in Quality Of Life (Health related quality of life score: Short Form 12) and new tricuspid regurgitation severity (more than mild TR from baseline). Additionally, cardiovascular mortality will be taken into consideration when evaluating results."
Answered by AI
How many participants are being included in this medical trial?
"Affirmative. The entry for this clinical trial on clinicaltrials.gov reveals that patient recruitment is ongoing, with the original posting date being September 1st 2022 and the last update occurring October 24th 2022. At present, there is a requirement of 100 participants to be sourced from one medical centre."
Answered by AI
Is participation in this experiment available for qualified volunteers?
"Affirmative. According to the clinicaltrials.gov database, this healthcare study is actively enrolling patients. It was initially posted on September 1st 2022 and last modified on October 24th 2022; 100 participants have yet to be recruited from a single centre."
Answered by AI
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