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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pacemaker DDD Heart Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective open-label randomized controlled trial (1:1) with blinded outcome adjudication

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded outcome adjudication

Study Groups

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left bundle branch pacing

Group Type EXPERIMENTAL

Left bundle branch pacing lead (Select Secure 3830 lead)

Intervention Type DEVICE

Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing

Right ventricular pacing

Group Type ACTIVE_COMPARATOR

Right ventricular active fixation lead

Intervention Type DEVICE

Active fixation lead (standard)

Interventions

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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

Intervention Type DEVICE

Right ventricular active fixation lead

Active fixation lead (standard)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No