New Study Finds BIOTRONIK’s CRT-DX Technology Enables Effective CRT-D Therapy with Fewer Leads

Presentation on CRT-NEXT Study at ACC Conference Highlights Similar Primary Outcomes Compared to Conventional CRT-D, Fewer Atrial‑Lead Complications and Shorter Procedures with 2-Lead CRT-D System

Results from the multicenter CRT‑NEXT Study show that CRT‑DX, BIOTRONIK’s 2-lead CRT-D system, is as safe and effective as conventional 3-lead CRT‑D therapy. The study confirms that most CRT candidates do not develop the need for atrial pacing in the long term and can benefit from therapy with fewer leads. Coordinating Investigator Dr. Mauro Biffi presented the novel data at the American College of

Cardiology (ACC) Annual Scientific Session in New Orleans. The results have also been published online in Circulation. 

CRT‑NEXT is a prospective, multicenter, randomized, controlled, interventional study that enrolled 636 patients across 23 Italian centers. It is the largest evaluation to date of CRT-DX therapy—a cardiac resynchronization defibrillator system that preserves full atrial sensing capabilities without requiring an atrial lead. The study demonstrated: 

• Three times fewer atrial‑lead–related complications compared to conventional 3-lead systems 
• 14% shorter implantation procedures, potentially improving workflow efficiency and reducing patient burden 
• Comparable CRT response rates and functional capacity outcomes 
• Extremely rare long‑term need for atrial pacing in appropriately selected CRT‑DX patients 

“These results confirm what early pilot studies suggested: that for the vast majority of CRT candidates, atrial pacing is not needed in the long term,” said Dr. Mauro Biffi, Clinical Cardiologist and Director of Electrophysiology at Sant'Orsola-Malpighi Polyclinic, Bologna, Italy. “By removing the atrial lead, CRT‑DX offers meaningful advantages in safety and procedure simplification—without compromising clinical performance.” 

The study reinforces the clinical relevance of CRT‑DX technology by showing that patient selection is based on simple criteria. This makes it easier for physicians, including those new to the system, to adopt the approach. With strong evidence supporting its non‑inferiority to conventional CRT-D systems, along with better safety due to fewer atrial-lead related issues, CRT-DX offers a compelling new way using reduced hardware while preserving therapeutic effectiveness. 

“BIOTRONIK’s CRT-DX system is the only 2-lead CRT‑D solution on the market,” said Dr. David Hayes, Chief Medical Officer at BIOTRONIK. “The CRT‑NEXT results clearly demonstrate the system’s distinct advantages for both clinicians and patients. This data reinforces our leadership in CRT innovation and offers strong clinical support for a significant evolution in CRT treatment.” 

About BIOTRONIK 

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.