IRVINE, Calif., October 10, 2025 — Johnson & Johnson MedTech has announced the launch of the CORE-VA (Catheter-based Outcomes Registry for Ventricular Arrhythmia) Registry, a pioneering real-world clinical outcomes program designed to enhance ventricular arrhythmia ablation care. Developed in partnership with leading electrophysiologists and medical centers, the registry aims to collect and analyze comprehensive procedural data to improve safety, precision, and long-term results for patients undergoing cardiac ablation.

Science Significance

The CORE-VA Registry represents a scientific leap forward in electrophysiology and cardiac intervention, combining AI-powered analytics, advanced imaging, and procedural mapping. This initiative will assess how catheter ablation technologies perform across diverse patient populations, enabling clinicians to refine strategies for ventricular arrhythmia management. By integrating real-world data from hospitals and clinics globally, the registry will strengthen understanding of treatment outcomes, complication trends, and procedural efficiency in high-risk cardiac patients.

Regulatory Significance

The initiative aligns with FDA Real-World Evidence (RWE) guidance, promoting post-market clinical data collection to inform device performance, labeling, and safety. The registry will serve as a foundation for regulatory submissions supporting next-generation ablation technologies and procedural tools. This marks a milestone in how regulators and MedTech companies collaborate to enhance post-market surveillance and ensure evidence-based decision-making in cardiovascular device management.

Business Significance

For Johnson & Johnson MedTech, the CORE-VA Registry underscores its leadership in digital innovation and evidence-based care. The initiative reinforces the strategic vision of its Biosense Webster business unit, advancing the company’s dominance in catheter ablation and electrophysiology. By integrating AI, big data, and clinical outcomes research, J&J strengthens its global position in the rapidly expanding MedTech digital ecosystem, estimated to surpass $80 billion by 2030.

Patients’ Significance

Ventricular arrhythmias are among the most life-threatening cardiac conditions, often leading to sudden cardiac arrest. The registry’s real-world data will enable personalized treatment planning, helping physicians predict patient response, minimize recurrence, and improve survival. Patients will ultimately benefit from safer procedures, faster recovery, and enhanced quality of life. This initiative reflects J&J’s ongoing mission to transform cardiac care through innovation and compassion.

Policy Significance

The launch of the CORE-VA Registry aligns with global policy goals that promote precision medicine, real-world data integration, and digital health transformation. It supports efforts by U.S. and international health agencies to modernize medical device surveillance and data transparency. This collaboration sets a precedent for how industry, clinicians, and regulators can work together to improve healthcare outcomes through technology and data-driven policy reform.

Johnson & Johnson MedTech’s CORE-VA Registry marks a new era in cardiac care. By integrating real-world evidence, AI analytics, and collaborative research, the initiative aims to transform how clinicians understand and perform ventricular arrhythmia ablation. This bold step reinforces J&J’s commitment to advancing patient-centered innovation, ensuring that every procedure contributes to safer, smarter, and more effective cardiovascular medicine worldwide.

Source: Johnson & Johnson MedTech press release