Why the study?
CRT-D carries risks of infection and lead functionality loss related to intravascular hardware, prompting evaluation of the safety and efficacy of a two-lead DX-based CRT system versus a conventional three-lead system.
Does a two-lead DX-based CRT system provide equivalent clinical outcomes compared to a conventional three-lead CRT-D system in patients meeting CRT indications without sick sinus syndrome?
Population
210 patients meeting CRT indications and no signs of sick sinus syndrome
Comparison
Two-lead DX-based CRT system vs conventional three-lead CRT-D system
Design
Single-center prospective non-randomized study
Follow-up
Mean 46.5 ± 1.9 months
Key result
The two-lead DX-based CRT system resulted in a similar rate of the composite clinical endpoint of cardiovascular death, heart failure hospitalization, or new-onset atrial fibrillation compared to a conventional three-lead system (HR 0.76).
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May support two-lead DX CRT to reduce hardware in eligible patients; leaves open randomized confirmation of equivalence.
Cohort (n=210)
No
Does a two-lead DX-based CRT system provide equivalent clinical outcomes compared to a conventional three-lead CRT-D system in patients meeting CRT indications without sick sinus syndrome?
Hazard Ratio: 0.76 (95% CI 0.47–1.2)
Absolute Event Rate: 31.9% vs 39.8%
p-value: p=0.23
A two-lead DX-based CRT system offers a safe and effective alternative to conventional three-lead CRT-D, providing equivalent clinical benefits with reduced intravascular hardware in patients without an indication for atrial pacing.
A 2025 study conducted a cohort in Heart failure with indication for cardiac resynchronization therapy (n=210). Two-lead DX-based CRT system vs. Conventional three-lead CRT-D system was evaluated on Composite of cardiovascular death, heart failure hospitalization, or new-onset atrial fibrillation (HR 0.76, 95% CI 0.47-1.20, p=0.23). The two-lead DX-based CRT system resulted in a similar rate of the composite clinical endpoint of cardiovascular death, heart failure hospitalization, or new-onset atrial fibrillation compared to a conventional three-lead system (HR 0.76).
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