CCM OPEN HF Registry

Clinical Trial Title CCM Technologies OPEN HF Registry: Observational Patient Evaluation of CCM Therapy for Heart Failure
Trial Status Open to Enrollment
Start Date 05/12/2026
Location Legacy Emanuel Medical Center
Trial Type Heart Disease/Cardiology
Specific Condition Heart failure
Description This is a registry for an FDA-approved heart failure therapy called cardiac contractility modulation, also known as CCM therapy. Heart failure is treated with medications to improve the strength of the heart muscle and reduce the amount of work the heart must do. However, medications are not always successful in making heart failure patients feel better. The CCM Device is indicated for patients that remain symptomatic despite best efforts to treat the condition with medications.

The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.

This is a global, prospective and retrospective, multicenter, single-arm, observational study intended to include patients who will receive/have received CCM therapy with an Impulse Dynamics system, including future CCM technologies (e.g. CCM-D), for a follow-up period of at least 5 years. This registry will uniformly gather real-world data from clinical sites adhering to standard-of-care protocols for subjects receiving CCM therapy.
 
Eligibility Criteria

Inclusion Criteria:

  • Patients who have /will be implanted with Impulse Dynamics CCM technologies (e.g. CCM or CCM-D when available) as determined by investigators
  • Willing and able to provide informed consent, including for use of data for research purposes (e.g. publication, sub-studies/sub-analyses)
IRB Number 10920
Notes
Principal Investigator Brendan Daly, MD
Contact Name Jon Cook
Contact Phone 503-413-8330
Contact Fax 503-413-6861
Contact E-Mail johcook@lhs.org