Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing

Pacemaker DDD Clinical Trial

Official title:

LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015660
• Other study ID #: 2021-7452
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Jacqueline Joza, MD MSc
• Phone: 514-934-1934
• Email: jacqueline.joza[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.

Description:

We hypothesize that in patients with high degree AV block with anticipated ventricular pacing >90%, and an EF >35% patients undergoing LBBP will demonstrate a significantly lower number of the primary composite endpoint of cardiovascular death, heart failure events, and change in LVESVi as compared to standard RV pacing. Echos will be performed at baseline, 12, 24, and 36 months. NTproBNPs are performed at baseline and follow-up. There will be a core echo lab, and blinded adjudication of ECGs and events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patients with an ejection fraction of >35%

3. Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including:

1. Third degree AV block

2. Symptomatic or asymptomatic second-degree AV block

3. First degree AV block = 280ms with a narrow QRS, or = 240ms with an intraventricular delay (QRS duration =120ms)

4. Echocardiogram within the last 3 months, with ability to have DICOM images

Exclusion Criteria:

1. Indication for an implantable cardioverter defibrillator

2. Presence of a mechanical tricuspid valve

3. Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP

4. Lack of capacity to consent

5. Other serious medical condition with life expectancy of <2 years

6. Pregnancy

7. Patients in whom the conduction system abnormality is expected to be transient or recover over time

8. Patients with permanent atrial fibrillation

Related Conditions & MeSH terms

• Heart Block
• Pacemaker DDD

Intervention

Device:
• Left bundle branch pacing lead (Select Secure 3830 lead)
Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing
• Right ventricular active fixation lead
Active fixation lead (standard)

Locations

Country	Name	City	State
Canada	McGill University Health Centre-Research Institute	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cardiovascular death	Clinical	36 months
Primary	Time to first heart failure event	Defined as: (i) Emergency department (ED) visits or hospitalization for HF (requiring signs and symptoms consistent with congestive heart failure (CHF) that is responsive to oral or parenteral medications); (ii) intensification of therapy (intravenous diuretic therapy on an outpatient basis); or (iii) indication for device upgrade to CRT due to deteriorating LV function defined as an absolute decline in LVEF = 10% from baseline and an LVEF = 40%	36 months
Primary	Worsening LV end systolic vloume index at 2 years	Defined as a 15% increase from baseline on the two-year echo	24 months
Secondary	Cardiovascular mortality	CV-related	24 months
Secondary	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.	24 months
Secondary	Total mortality	Total mortality	24 months
Secondary	Change in left ventricular ejection fraction	Echo parameter, change from baseline to 24 months	24 months
Secondary	Change in NTproBNP level	From baseline to 24 months	24 months
Secondary	Atrial fibrillation progression	Atrial fibrillation burden as noted on pacemaker	24 months
Secondary	Development of new tricuspid regurgitation	More than mild TR from baseline	24 months
Secondary	Presence of Mitral regurgitation	Progression/Development from baseline	24 months
Secondary	Change in Lead parameter	stability of impedance, sensing, thresholds	24 months
Secondary	Quality of Life Improvement	Health related quality of life score: Short Form 12	Evaluated at 1, 12, and 24 months, measure as compared to baseline
Secondary	Safety of procedure and long-term safety	Procedural and long-term safety of left bundle pacing	24 months