Observational Study of CCM Therapy with Impulse Dynamics Devices for Heart Failure Patients Long-Term Follow-Up on Safety and Effectiveness

What this Trial Is About

Researchers are investigating the long-term safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure. This global study combines both past and future patient data to observe how CCM therapy, delivered through Impulse Dynamics devices, performs in real-world settings over extended periods. The goal is to better understand CCM therapys impact on heart failure outcomes and any related device or procedure complications. The study includes patients who have already received or will receive CCM therapy using Impulse Dynamics systems, including future technologies like CCM-D. It is a single-arm observational study without experimental treatment groups, following patients for at least five years after their therapy. Patients are grouped into prospective, retrospective, and hybrid cohorts based on when they receive or received the CCM therapy. Participants will be monitored through regular follow-ups to assess hospitalization rates and length of stay due to heart failure, safety regarding device-related complications, and various clinical outcomes such as mortality, functional capacity, and heart remodeling. Additional evaluations include quality of life measurements using the Kansas City Cardiomyopathy Questionnaire and assessments of therapy compliance. The study duration allows detailed observation of CCM therapy effects and patient health over several years, up to at least five years.

CCM OPEN HF Registry