CCM OPEN HF Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure
Overview
The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.
Detailed description
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.
Primary outcome measures
- Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations [Time frame: 1 Year]
- Demonstrate the long-term safety of CCM therapy in a real-world setting, by assessing the rate of device- or procedure-related complications. [Time frame: 5 Years]
Secondary outcome measures (12)
- Assess CCM's effect on clinical outcomes [Time frame: 5 Years]
- Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related) [Time frame: 5 Year]
- Assess CCM's effect on healthy days at home (HDAH) [Time frame: 3 Years]
- Assess CCM's effect on functional capacity [Time frame: 5 Year]
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: 1 Year]
- Assess CCM's effect cardiovascular reverse remodeling [Time frame: 5 Year]
- Assess CCM's effect QRS duration [Time frame: 5 Years]
- Assess CCM's systemic effects [Time frame: 5 Years]
- Assess long-term CCM device-related adverse events and lead related events [Time frame: 5 Years]
- Assess the dose response of CCM therapy [Time frame: 5 Year]
- Evaluate subject battery charging compliance [Time frame: 5 Year]
- Assess the effect of ancillary equipment on clinical outcomes [Time frame: 5 Years]
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)
Exclusion criteria
- Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
- Subjects with a mechanical tricuspid valve
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 28 centers
- Cardiovascular Associates of Mesa — Mesa
- University of Arizona and Banner University Medical Center Phoenix — Phoenix
- HonorHealth Research Institute — Phoenix
- Peak Heart and Vascular — Surprise
- AdventHealth Orlando — Orlando
- AdventHealth Tampa — Tampa
- University of Kansas Medical Center — Kansas City
- Massachusetts General Hospital — Boston
- … and 20 more centers
Identifiers
NCT: NCT07112924 · OPEN_CA_CP_2025