Back to resultsConduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
Primary Purpose
Pacemaker DDD, Heart Block
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Left bundle branch pacing lead (Select Secure 3830 lead)
Right ventricular active fixation lead
Sponsored by
About this trial
This is an interventional treatment trial for Pacemaker DDD focused on measuring left bundle branch pacing
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patients with an ejection fraction of ≥50%
Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including:
- Third degree AV block
- Symptomatic or asymptomatic second-degree AV block
- First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
- Echocardiogram within the last 3 months, with ability to have DICOM images
Exclusion Criteria:
- Indication for an implantable cardioverter defibrillator
- Presence of a mechanical tricuspid valve
- Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
- Lack of capacity to consent
- Other serious medical condition with life expectancy of <2 years
- Pregnancy
- Patients in whom the conduction system abnormality is expected to be transient or recover over time
- Patients with permanent atrial fibrillation
Sites / Locations
- McGill University Health Centre-Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
left bundle branch pacing
Right ventricular pacing
Arm Description
Outcomes
Primary Outcome Measures
Left ventricular end systolic volume index
Echo parameter
Successful implant
Implant success after 4 attempts at left bundle pacing
Feasibility of recruitment
100 patients over 7 centers over 18 months recruitment
Secondary Outcome Measures
Cardiovascular mortality
CV-related
New visit for Heart Failure
Heart failure visit is defined as: i) Emergency department visit or hospitalization for signs and symptoms of HF that is responsive to oral or intravenous diuretics ii) intensification of therapy defined as outpatient intravenous diuretic therapy, and iii) device upgrade to cardiac resynchronization therapy.
Total mortality
Total mortality
Change in left ventricular ejection fraction
Echo parameter, change from baseline to 24 months
Change in NTproBNP level
From baseline to 24 months
Atrial fibrillation progression
Atrial fibrillation burden as noted on pacemaker
Development of new tricuspid regurgitation
More than mild TR from baseline
Presence of Mitral regurgitation
Progression/Development from baseline
Change in Lead parameter
stability of impedance, sensing, thresholds
Quality of Life Improvement
Health related quality of life score: Short Form 12
Safety of procedure and long-term safety
Procedural and long-term safety of left bundle pacing
Full Information
NCT ID
NCT05015660
First Posted
August 10, 2021
Last Updated
October 24, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Heart and Stroke Foundation of Canada, Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT05015660
Brief Title
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
Official Title
LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Heart and Stroke Foundation of Canada, Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has recently emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.
Detailed Description
In this vanguard study, the investigators hypothesize that in patients with high degree AV block and normal to mild LV dysfunction (LVEF >= 50%), patients undergoing LBBP will demonstrate a significantly lower indexed LV end-systolic volume (LVESVi) as compared to those undergoing RV pacing over 24 months follow-up. The investigators will demonstrate that recruitment is feasible, LBBP can be successfully performed with reproducible and consistent results, and that LVESVi will prove to be a suitable efficacy endpoint to inform the design and proceed with the pivotal LEFT-HF study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacemaker DDD, Heart Block
Keywords
left bundle branch pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective open-label randomized controlled trial (1:1) with blinded outcome adjudication
Masking
Outcomes Assessor
Masking Description
Blinded outcome adjudication
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
left bundle branch pacing
Arm Type
Experimental
Arm Title
Right ventricular pacing
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Left bundle branch pacing lead (Select Secure 3830 lead)
Intervention Description
Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing
Intervention Type
Device
Intervention Name(s)
Right ventricular active fixation lead
Intervention Description
Active fixation lead (standard)
Primary Outcome Measure Information:
Title
Left ventricular end systolic volume index
Description
Echo parameter
Time Frame
24 months
Title
Successful implant
Description
Implant success after 4 attempts at left bundle pacing
Time Frame
30 days
Title
Feasibility of recruitment
Description
100 patients over 7 centers over 18 months recruitment
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality
Description
CV-related
Time Frame
24 months
Title
New visit for Heart Failure
Description
Heart failure visit is defined as: i) Emergency department visit or hospitalization for signs and symptoms of HF that is responsive to oral or intravenous diuretics ii) intensification of therapy defined as outpatient intravenous diuretic therapy, and iii) device upgrade to cardiac resynchronization therapy.
Time Frame
24 months
Title
Total mortality
Description
Total mortality
Time Frame
24 months
Title
Change in left ventricular ejection fraction
Description
Echo parameter, change from baseline to 24 months
Time Frame
24 months
Title
Change in NTproBNP level
Description
From baseline to 24 months
Time Frame
24 months
Title
Atrial fibrillation progression
Description
Atrial fibrillation burden as noted on pacemaker
Time Frame
24 months
Title
Development of new tricuspid regurgitation
Description
More than mild TR from baseline
Time Frame
24 months
Title
Presence of Mitral regurgitation
Description
Progression/Development from baseline
Time Frame
24 months
Title
Change in Lead parameter
Description
stability of impedance, sensing, thresholds
Time Frame
24 months
Title
Quality of Life Improvement
Description
Health related quality of life score: Short Form 12
Time Frame
Evaluated at 1, 12, and 24 months, measure as compared to baseline
Title
Safety of procedure and long-term safety
Description
Procedural and long-term safety of left bundle pacing
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patients with an ejection fraction of ≥50%
Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including:
Third degree AV block
Symptomatic or asymptomatic second-degree AV block
First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
Echocardiogram within the last 3 months, with ability to have DICOM images
Exclusion Criteria:
Indication for an implantable cardioverter defibrillator
Presence of a mechanical tricuspid valve
Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
Lack of capacity to consent
Other serious medical condition with life expectancy of <2 years
Pregnancy
Patients in whom the conduction system abnormality is expected to be transient or recover over time
Patients with permanent atrial fibrillation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Joza, MD MSc
Phone
514-934-1934
Ext
43158
Email
jacqueline.joza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fiorella Rafti, PhD
Phone
514-934-1934
Email
fiorella.rafti@mail.mcgill.ca
Facility Information:
Facility Name
McGill University Health Centre-Research Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Y2T6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiorella Rafti, PhD
Phone
514-934-1934
Email
fiorella.rafti@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Jacqueline Joza
Phone
514-934-1934
Ext
43158
Email
jacqueline.joza@gmail.com
First Name & Middle Initial & Last Name & Degree
Jacqueline Joza
First Name & Middle Initial & Last Name & Degree
Atul Verma
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
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