Background/Objectives: Patients with normal sinus rhythms undergoing cardiac resynchronization therapy defibrillator (CRT-D) implantation may benefit from a novel two-lead CRT-D system (CRT-DX), which features an atrial sensing dipole integrated into the right ventricular lead. This single-arm, international, non-controlled investigation focused on the safety and clinical efficacy of CRT-DX devices in CRT-D candidates who do not require atrial pacing. Methods: Patients indicated for CRT-D implantation (resting heart rates > 40 bpm and ≥100 bpm during exercise, no second or higher-degree AV block, and no history of persistent or permanent atrial fibrillation) were enrolled across 21 sites in four European countries. The primary endpoint was the need for an additional RA lead implantation within 12 months. Secondary endpoints comprised any invasive re-intervention to the CRT-DX system or infection. Results: Among the 110 patients (mean age 62 years, 70% male), 60% had an underlying non-ischemic cardiac disease. During 12 months of follow-up, RA lead implantation was required in two patients for atrial undersensing or chronotropic incompetence (RA lead implantation-free rate: 98.2% (95% CI: 92.7-99.5%)). Atrial sensing amplitudes were stable (mean: 4.7 ± 1.7 mV), AV-synchrony was maintained at >99%, and the median percentage of biventricular pacing exceeded 98%. The left ventricular ejection fraction improved by an absolute 14.7%. Conclusions: Using simple, clinically applicable inclusion criteria, the two-lead CRT-DX system demonstrated a low rate of subsequent RA lead implantations (1.8%) and maintained adequate RA sensing amplitudes throughout the observation period. The two-lead CRT-DX concept appears to be a feasible alternative for patients with preserved chronotropic competence.

2nd Department of Medicine Westpfalz Klinikum 67655 Kaiserslautern Germany

Biotronik 12359 Berlin Germany

Department of Cardiology Friedrich Alexander Universität Erlangen Nuremberg 91054 Erlangen Germany

Department of Cardiology German Heart Centre TUM University Hospital Technical University of Munich 80636 Munich Germany

Department of Cardiology Rhythmology Angiology and Intensive Care Medicine Heart Centre Osnabrück Hospital Osnabrück Westphalian Wilhelms University of Münster 49076 Osnabrück Germany

Department of Cardiology University Hospital Medical Faculty Johannes Kepler University 4020 Linz Austria

Department of Cardiology University Hospital Olomouc 77900 Olomouc Czech Republic

Heart and Vascular Center Semmelweis Medical University 1122 Budapest Hungary

Heart Center Bad Neustadt 97616 Bad Neustadt Germany

Internal Medicine 1 University Hospital Würzburg 97080 Würzburg Germany

Medical Faculty Christian Albrechts University 24105 Kiel Germany

Partner Site Munich Heart Alliance German Centre for Cardiovascular Research 80636 Munich Germany

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