# CRT zonder atriale lead: tweeledig CRT-DX-systeem non-inferieur aan klassieke drie-leads CRT-D

*geplaatst 2026-04-25 · Algemeen · Circulation · doi https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.126.079859 · https://hartvaat.nl/2026/03/30/crt-zonder-atriale-lead-tweeledig-crt-dx-systeem-non-inferieur-aan-klassieke-dri/*

In deze Italiaanse multicenter-RCT (n=636) bleek een CRT-DX-systeem met atriale sensing via een floating dipole op de RV-lead non-inferieur aan de standaard drie-lead CRT-D op het composiet eindpunt van mortaliteit, cardiovasculaire opname en leadcomplicaties op één jaar. Voor CRT-D-patiënten zonder sinusknoopdysfunctie is de vereenvoudiging klinisch interessant: minder leads, minder complicaties.

## English: 

In this Italian multicenter RCT (n=636), a two-lead CRT-DX system with atrial sensing via a floating dipole on the RV lead was non-inferior to standard three-lead CRT-D on the 1-year composite of mortality, cardiovascular hospitalisation, and lead-related complications. For CRT-D candidates without sinus node dysfunction, the simplification is clinically appealing: fewer leads, fewer complications.

## Abstract (original, from the publication)

Background: The role of atrial pacing support is unclear in cardiac resynchronization therapy-defibrillator (CRT-D) patients without sinus node dysfunction.Methods: We conducted a randomized, parallel-group, non-inferiority trial to evaluate whether a two-lead CRT-DX system capable of atrial sensing (but no pacing) via a floating dipole on the right ventricular lead is not inferior to a three-lead CRT-D with conventional atrial lead. Between October 17, 2018, and March 5, 2024, 636 patients (68 ± 10 years old, 28.6% females) with standard CRT-D indication, optimized medical therapy, and resting sinus rate ≥45 beats/min were randomized 1:1 to CRT-DX (VDD 35 beats/min) or CRT-D (DDD 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 endpoint was a 1-year composite of all-cause mortality, cardiovascular hospitalization, and lead-related complications (loss of functionality not correctable by device reprogramming). Key secondary endpoints were each component, echocardiographic reverse remodeling, and 6-minute walk test distance at 12 months.Results: The primary endpoint 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 non-inferiority (pre-specified relative margin of 1.20) in both the per-protocol (p=0.039) and intention-to-treat (p=0.044) analyses. Individual components showed no significant differences, except for lead complications related to right atrial functionality (4 [1.3% ] patients in the CRT-DX group vs. 13 [4.2%] patients in the CRT-D group; p=0.040). Reverse remodeling responders were 203 (77.5% of 262) CRT-DX patients and 190 (76.3% of 249) CRT-D patients (p=0.83). Walking distance did not differ between two study arms (404 vs. 398 m; p=0.62). After median follow-up of 2.4 years, only one CRT-DX patient required implantation of a standard atrial lead.Conclusions: Two-lead CRT-DX system without atrial pacing is non-inferior to conventional three-lead CRT-D, with fewer atrial lead-related complications.

Auteurs: Mauro Biffi

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Bron: Circulation, https://doi.org/https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.126.079859. Bijgewerkt 2026-07-03T13:31:43Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.