Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm

Inclusion criteria

• Patient is able to understand the nature of study and has provided written informed consent.
• Patient is willing and able to perform all follow up visits at the study site.
• Patient is willing and able to use the CardioMessenger® and accepts the BIOTRONIK Home Monitoring® concept.
• CRT-D is indicated according to the current ESC guidelines.
• De novo implantation with no pre-existing defibrillator or pacemaker system
• Patient is in sinus rhythm without history of persistent or permanent atrial fibrillation.
• Patient has no atrioventricular (AV) block II or III.
• Patient has no evidence of impaired sinus node function.
• Patient has no need for atrial stimulation, has a resting heart rate (HR) > 40 b.p.m and achieves a peak HR ≥100 b.p.m even under intended dosage of HR lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment
• NYHA class II or III
• Patient receives guideline-based optimized medical therapy for HF including heart-rate lowering medication at the time of enrollment

Exclusion criteria

• Patient is pregnant or breast feeding.
• Patient is less than 18 years old.
• Patient is participating in an interventional clinical investigation.
• Life-expectancy is less than 1 year.
• Patient has tachycardia-bradycardia syndrome
• Any standard contraindication for CRT-D
• Frequent premature ventricular contractions (PVC rate > 5 %/h) examined within 3 months prior to enrollment by appropriate routine method (e.g. 24 h holter electrocardiogram)