Left bundle branch pacing lead (Select Secure 3830 lead) for Heart Block

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McGill University Health Centre-Research Institute, Montreal, Canada
Heart Block+1 More
Left bundle branch pacing lead (Select Secure 3830 lead) - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new pacing mode called left bundle branch pacing (LBBP) might be a better alternative to right ventricular (RV) pacing.

See full description

Eligible Conditions

  • Heart Block
  • Pacemaker DDD

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Left bundle branch pacing lead (Select Secure 3830 lead) will improve 3 primary outcomes and 11 secondary outcomes in patients with Heart Block. Measurement will happen over the course of 30 days.

18 months
Feasibility of recruitment
24 months
Atrial fibrillation progression
Cardiovascular mortality
Change in Lead parameter
Change in NTproBNP level
Change in left ventricular ejection fraction
Development of new tricuspid regurgitation
Left ventricular end systolic volume index
New visit for Heart Failure
Presence of Mitral regurgitation
Safety of procedure and long-term safety
Total mortality
30 days
Successful implant
Month 24
Quality of Life Improvement

Trial Safety

Trial Design

2 Treatment Groups

Right ventricular pacing
1 of 2
left bundle branch pacing
1 of 2
Active Control
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Left Bundle Branch Pacing Lead (Select Secure 3830 Lead) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

left bundle branch pacing
Device
Right ventricular pacing
Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated at 1, 12, and 24 months, measure as compared to baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly evaluated at 1, 12, and 24 months, measure as compared to baseline for reporting.

Who is running the study

Principal Investigator
J. J.
Jacqueline Joza, Cardiac electrophysiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre

Closest Location

McGill University Health Centre-Research Institute - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If the interval between successive heartbeats is greater than 280 milliseconds, or if the QRS complex is narrow with a duration of at least 120 milliseconds, this is considered first degree AV block. show original
An echocardiogram within the last 3 months is required, with the ability to have DICOM images. show original
The person is 18 years or older. show original
Patients with an ejection fraction of ≥50%
Third degree AV block
Symptomatic or asymptomatic second-degree AV block

Patient Q&A Section

What are common treatments for heart block?

"Treatment is focused on symptom management rather than a cure for the underlying disease, which can be treated through many forms of therapy. It was difficult to identify specific therapies for any condition." - Anonymous Online Contributor

Unverified Answer

What causes heart block?

"Heart block can have many causes ranging from benign changes, to serious, sometimes fatal condition of the heart muscle. Most causes related to the heart can be traced to arrhythmias or the abnormalities related to the electrical conduction system of the heart, the bundle of hearts." - Anonymous Online Contributor

Unverified Answer

Can heart block be cured?

"In cases treated by PACE, there was a significant and statistically significant trend toward a lower risk of recurrent block or death in patients with complete heart block compared with patients with a remaining first-degree block." - Anonymous Online Contributor

Unverified Answer

What is heart block?

"Heart block results from an interruption in the electrical conduction system of the heart. Most blocks originate in the sinoatrial node, although other sites, such as the atrioventricular node and bundle branches, also play an active role.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of heart block?

"Signs of heart block include chest pain, a feeling of pressure or discomfort in the chest, blurred vision, and weakness in the face or legs.\n" - Anonymous Online Contributor

Unverified Answer

How many people get heart block a year in the United States?

"Approximately 6,200 Americans will develop bradycardia each year due to heart block. The age-adjusted risk was highest in the second- to fifth-decade age groups (10.0-4.6%) but was much higher in younger age groups (42.8%). Women (16.6%) and blacks (14.6%) are more likely to develop heart block than whites (7.2%)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of heart block?

"Most patients with secondary heart block have a prolonged PR interval, in contrast to patients with primary heart block. Myocardial fibrosis may explain the higher incidence of primary versus secondary heart block in these two groups. The low degree of QRS distortion in the majority of cases suggests that an early termination of this distortion process could be responsible for the occurrence of the more severe form of arrhythmia." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in left bundle branch pacing lead (select secure 3830 lead) for therapeutic use?

"Select Secure leads demonstrate improved lead integrity and safety compared with standard Secure leads. Use of a selective Secure lead in patients with significant heart block is being increasingly accepted and is well tolerated. Our first results show that using a Select Secure lead in the treatment of left bundle branch block could be beneficial. The current generation of Select Secure leads has become a tool for therapeutic intervention in patients with significant heart block in a variety of clinical applications." - Anonymous Online Contributor

Unverified Answer

How does left bundle branch pacing lead (select secure 3830 lead) work?

"Use of a 3830 leads with LVAP leads is safe and effective in stimulating left ventricular function. These leads exhibit fewer side effects and are more economical compared to the use of conventional leads." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets heart block?

"Most patients get heart block at a younger age (i.e., under 40) than they think they do. Younger patients tend to overestimate the true frequency of the heart block they are getting and thus over-treat for the symptoms of the disease." - Anonymous Online Contributor

Unverified Answer

Is left bundle branch pacing lead (select secure 3830 lead) safe for people?

"LV BBR pacing leads are safe and effective for people with LV dysfunction and LV lead complications are low. A small percentage may experience some lead problems. It should not be surprising that no lead problems occurred in patients who had all three of the following complications: no pacing leads in place, no P-wave progression, and no P-wave axis >160 deg." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for heart block?

"A substantial minority of patients with left bundle branch block may be eligible for clinical trials. Those with mild or moderate symptoms with no evidence of disease, and those who are asymptomatic with nonspecific ECGs, should strongly be considered for therapeutic clinical trials. Because of the limitations in the numbers of patients in clinical trials, a large enough sample size is needed before determining the benefit of one treatment modality in comparison with another. The presence of other heart disease is a contraindication to participation in clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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