Safety and Performance Study of New Heart Rhythm Devices

This trial is testing the CorSky family of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) — devices that are implanted under the skin to help regulate dangerous heart rhythms and support heart function. Researchers want to confirm that these new devices work safely and effectively in patients who need them. The CorSky devices are the next generation of technology from BIOTRONIK, building on proven earlier models.

As with any new medical device, manufacturers must conduct studies after the devices are available to patients to verify they perform as intended and are safe over time. This study ensures the new treatment meets all safety and performance expectations in real-world use.