Trial reportCirculation2026
Role of Atrial Pacing Support in Cardiac Resynchronization Therapy: A Noninferiority Randomized Trial.
Trial report in Circulation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03587064 (Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Non-inferiority Randomized Clinical Investigation of CRT-DX Versus CRT-D Systems
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Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe role of atrial pacing support is unclear in patients receiving cardiac resynchronization therapy-defibrillator (CRT-D) without sinus node dysfunction.
methodsWe conducted a randomized, parallel-group, noninferiority trial to evaluate whether a 2-lead CRT-D capable of atrial sensing (but no pacing) by a floating dipole on the right ventricular lead (CRT-DX) is not inferior to a 3-lead CRT-D with a conventional atrial lead. Between October 17, 2018, and March 5, 2024, a total of 636 patients (68±10 years old, 28.6% women) with standard CRT-D indication, optimized medical therapy, and resting sinus rate ≥45 beats/min were randomized 1:1 to CRT-DX (atrial tracking without atrial pacing mode 35 beats/min) or CRT-D (atrial tracking with atrial pacing mode 50 beats/min) at 23 Italian sites. A centralized block-randomization procedure stratified by site was used, with patients and primary outcome assessors blinded to treatment assignment. The primary end point was a 1-year composite of all-cause mortality, cardiovascular hospitalization, and lead-related complications (loss of functionality not correctable by device reprogramming). Secondary end points included each individual component of the primary end point separately, echocardiographic reverse remodeling, and 6-minute walk test distance at 12 months.
resultsThe primary end point occurred in 41 (13.1%) patients in the CRT-DX group and 47 (15.6%) patients in the CRT-D group, corresponding to a hazard ratio of 0.82 (95% CI, 0.54-1.25). This confirmed noninferiority (prespecified relative margin of 1.20) in both the per-protocol (
conclusionsThe 2-lead CRT-DX system without atrial pacing is noninferior to conventional 3-lead CRT-D, with fewer atrial lead-related complications. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03587064.
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