TABLE I.
Major Clinical Trials, by Left Ventricular Ejection Fraction Subpopulation, Comparing BVP, His Bundle Pacing, and Left Bundle Branch Area Pacing for CRT and Their Primary End Points
| Left ventricular ejection fraction ≤35% | Left ventricular ejection fraction 36%-49% | Left ventricular ejection fraction ≥50% |
|---|---|---|
| CSP-SYNC [NCT05155865] (CSP vs BIVP) (N = 60) End points: left ventricular ejection fraction, left ventricular volume, New York Heart Association classification, 6-minute walk test, quality of life |
His-PACE [NCT04672408] (His bundle pacing vs right ventricular pacing) (N = 50) End point: left ventricular ejection fraction |
|
| HIS-alt_2 [NCT04409119] (CSP vs BIVP) (N = 125) End points: left ventricular end-systolic volume, QRS duration |
HIS-PrEF [NCT04529577] (His bundle pacing vs right ventricular pacing) (N = 40) End point: left ventricular ejection fraction |
|
| HIS-CRT [NCT05265520] (His bundle pacing vs BIVP) (N = 120) End point: left ventricular ejection fraction |
LEAP [NCT04595487] (Left ventricular septal pacing vs right ventricular pacing) (N = 470) End points: death, HF hospitalizations, left ventricular ejection fraction decrease by 10% |
|
| His-SYNC [NCT02700425] (His bundle pacing vs BIVP) (N = 41) End point: QRS duration |
LEFT HF [NCT05015660] (Left bundle branch area pacing vs right ventricular pacing) (N = 1,280) End points: cardiovascular death, HF events |
|
| LeCaRT [NCT05365568] (Left bundle branch area pacing vs BIVP) (N = 170) End points: composite death, HF hospitalizations, worsening HF, implant failure, cardiac implantable electrical device re-intervention |
OptimPacing [NCT04624763] (Left bundle branch area pacing vs right ventricular pacing) (N = 683) End points: death, HF hospitalizations, pacemaker-induced cardiomyopathy |
|
| LIT-HF [NCT05572957] (CSP vs guideline-directed medical therapy) (N = 50) End point: left ventricular ejection fraction |
PROTECT-HF [NCT05815745] (His bundle pacing vs right ventricular pacing) (N = 2,600) End points: cardiovascular death, HF events |
|
| Left-Bundle CRT [NCT05434962] (Left bundle branch area pacing vs BIVP) (N = 176) End point: CRT response |
REINVENT-CRT [NCT05652218] (Left bundle branch area pacing vs BIVP) (N = 20) End point: myocardial perfusion imaging |
|
| PhysioSync-HF [NCT05572736] (CSP vs BIVP) (N = 304) End points: death, HF hospitalizations, left ventricular ejection fraction |
||
| CONSYST-CRT [NCT05187611] (CSP vs BIVP) (N = 130) End points: composite death, cardiac transplant, HF hospitalizations, and left ventricular ejection fraction |
LBB Pacing Versus Conventional Pacing in Atrioventricular Block [NCT05722379] (Left bundle branch area pacing vs right ventricular pacing) (N = 27) End point: global work efficiency |
|
| HIPPOS [NCT05491655] (His bundle pacing vs backup right ventricular pacing) (N = 34) End point: left ventricular ejection fraction |
RHYSPAVB [NCT05214365] (His bundle pacing vs right ventricular pacing) (N = 200) End point: pacemaker-induced cardiomyopathy |
|
| LBBAP-AFHF [NCT05549544] (Left bundle branch area pacing vs BIVP) (N = 60) End point: left ventricular ejection fraction |
Vanguard [NCT05015660] (Left bundle branch area pacing vs right ventricular pacing) (N = 100) End points: death, HF events, left ventricular end-systolic volume, changes in lead parameters, quality of life; and safety |
|
| LBB Pacing in Patients with Cardiac Dysfunction and AV Block [NCT05553626] (Left bundle branch area pacing vs BIVP) (N = 160) End point: left ventricular ejection fraction |
||
| Left vs Left [NCT05650658] (CSP vs BIVP) (N = 2,136) End points: death, HF hospitalizations, quality of life |
||
BIVP, biventricular pacing; CRT, cardiac resynchronization therapy; CSP, conduction system pacing; HF, heart failure.