L H R P

Loading

Refer Patient

LEFT Bundle Pacing vs Standard RV Pacing for Heart Failure

LEFT-HF

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

Lead PI & Sponsor

Dr. Jacqueline Joza

Local PI

Dr. Habib Khan

Research Staff

Sara El-Richani

Objective

The purpose of this study is to compare two pacemaker placement strategies Standard right ventricular pacing (control group) and Left bundle branch pacing (LBBP) (experimental group).

Target Number of Patients

75

Currently Enrolled

7

Primary Outcomes

  • Cardiovascular death and
  • Heart Failure Event defined as
    (i) Emergency Department (ED) visits or hospitalization for HF (requiring signs and symptoms consistent with congestive heart failure that is responsive to oral or parenteral medications),
    (ii) intensification of therapy (intravenous diuretic therapy on an outpatient basis),
    (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 ≤ 50%.
  • Worsening LV end systolic volume index (LVESVi) at 2 years defined as a 15% increase from baseline on the two-year echo.

Inclusion Criteria

  • Age > 18 years
  • Patients with an ejection fraction of >35%
  • Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including, but not limited to:
    a. Third degree AV block
    b. Symptomatic second degree AV block
    c. First degree AV block > 280 ms with a narrow QRS, or > 240 ms with an intraventricular delay (QRS duration > 120 ms)
  • An echocardiogram within the last 3 months

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
  • Patients in whom the conduction system abnormality is expected to be transient or recover over time.
  • Permanent atrial fibrillation.
  • Lack of capacity to consent or will have a substitute decision maker.
  • Other serious medical condition with life expectancy of < 2 years
  • Pregnancy or intention to become pregnant during the trial period

The purpose of this study is to compare two pacemaker placement strategies: a) standard righ ventricular pacing (control group); and b) left bundle branch pacing (LBBP) (experimental group). Typically, patients who have heart block become dependent on pacemakers (i.e. life saving-devices that allow the heart to pump in an organized manner) to deliver electrical signals. If a patient is completely dependent on these electrical signals, they are at a risk of developing a weakening of their heart muscle called pacing-induced cardiomyopathy which is often associated with the development of heart failure. This study, therefore is looking at left bundle branch pacing, which is a novel approach to placing a pacemaker that attempts to prevent the risk of pacing induced cardiomyopathy and prevent heart failure.

View Full Study