Why the study?
The clinical value of routine atrial pacing in CRT recipients without sinus node dysfunction remains uncertain, while additional transvenous leads increase procedural complexity and lead-related complications.
Does a simplified two-lead CRT-DX system without atrial pacing provide non-inferior outcomes compared to conventional three-lead CRT-D in CRT candidates without sinus node dysfunction?
RCT
Does a simplified two-lead CRT-DX system without atrial pacing provide non-inferior outcomes compared to conventional three-lead CRT-D in CRT candidates without sinus node dysfunction?
A simplified two-lead CRT-DX system without atrial pacing is non-inferior to conventional three-lead CRT-D in patients without sinus node dysfunction, offering shorter procedure times and fewer lead complications.
Supports two-lead CRT-DX to reduce implant time and atrial-lead risks; extends simplified CRT to patients without sinus node dysfunction.
Cardiac resynchronization therapy defibrillators traditionally require a dedicated right atrial lead to provide atrial sensing and pacing in addition to biventricular pacing. However, the clinical value of routine atrial pacing in CRT recipients without sinus node dysfunction remains uncertain, while additional transvenous leads increase procedural complexity and lead-related complications. The CRT-NEXT trial evaluated whether a simplified two-lead CRT-DX system, capable of atrial sensing through a floating atrial dipole but without atrial pacing, was non-inferior to conventional three-lead CRT-D. In this randomized non-inferiority trial, CRT-DX met the prespecified non-inferiority criterion for the composite endpoint of all-cause mortality, cardiovascular hospitalization, and lead-related complications at 12 months. Mortality, cardiovascular hospitalization, arrhythmic outcomes, reverse remodeling, and functional capacity were comparable between groups, while CRT-DX was associated with shorter procedure time and fewer atrial lead-related complications. Importantly, atrial sensing remained reliable during follow-up, CRT delivery was preserved, and only one patient required late atrial lead implantation. These findings challenge the routine need for atrial pacing support in carefully selected CRT-D candidates and suggest that reliable atrial sensing may be sufficient for most patients without sinus node dysfunction. Future integration of DX-based atrial sensing with conduction system pacing may further advance device simplification toward single-lead CRT-D platforms.
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Moghadam et al. (2026) conducted an RCT in Cardiac resynchronization therapy candidates without sinus node dysfunction. Two-lead CRT-DX system vs. Conventional three-lead CRT-D was evaluated on Composite of all-cause mortality, cardiovascular hospitalization, and lead-related complications at 12 months.
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