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CCM OPEN HF Registry

NCT07112924 · Impulse Dynamics
In plain English

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Official title
CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure
About this study
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.
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
Study design
Enrollment target: 5500 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-11-01
Estimated completion: 2036-08-01
Last updated: 2026-04-23
Primary outcomes
  • Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations (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. (5 Years)
Sponsor
Impulse Dynamics · industry
Contacts & investigators
ContactKarl Van Wygerden · contact · kvanwygerden@impulsedynamics.com · 856-642-9933
ContactErika Mednick · contact · emednick@impulsedynamics.com · 8454990412
InvestigatorAnthony Hong · study_director, Impulse Dynamics
InvestigatorLee Ming Boo · study_director, Impulse Dynamics
All locations (28)
Cardiovascular Associates of MesaRecruiting
Mesa, Arizona, United States
University of Arizona and Banner University Medical Center PhoenixNot Yet Recruiting
Phoenix, Arizona, United States
HonorHealth Research InstituteNot Yet Recruiting
Phoenix, Arizona, United States
Peak Heart and VascularRecruiting
Surprise, Arizona, United States
AdventHealth OrlandoNot Yet Recruiting
Orlando, Florida, United States
AdventHealth TampaNot Yet Recruiting
Tampa, Florida, United States
University of Kansas Medical CenterNot Yet Recruiting
Kansas City, Kansas, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
University of MichiganNot Yet Recruiting
Ann Arbor, Michigan, United States
Henry Ford Providence HospitalNot Yet Recruiting
Novi, Michigan, United States
Trinity Ann Arbor d/b/a Michigan Heart Ann ArborNot Yet Recruiting
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Research FoundationNot Yet Recruiting
Minneapolis, Minnesota, United States
Saint Luke's Hospital Mid America Heart InstituteNot Yet Recruiting
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas CityNot Yet Recruiting
Kansas City, Missouri, United States
Cardiovascular Specialists of New England Research FoundationNot Yet Recruiting
Londonderry, New Hampshire, United States
Deborah Heart and Lung CenterNot Yet Recruiting
Browns Mills, New Jersey, United States
Hackensack University Medical CenterNot Yet Recruiting
Hackensack, New Jersey, United States
Rutgers New Jersey Medical School & University HospitalNot Yet Recruiting
Newark, New Jersey, United States
Providence St. Vincent Medical CenterNot Yet Recruiting
Portland, Oregon, United States
Legacy Medical Group CardiologyNot Yet Recruiting
Portland, Oregon, United States
Reading HospitalNot Yet Recruiting
West Reading, Pennsylvania, United States
The Stern Cardiovascular Foundation, IncRecruiting
Germantown, Tennessee, United States
David Turbay, MDRecruiting
El Paso, Texas, United States
Texan Cardiovascular InstituteNot Yet Recruiting
El Paso, Texas, United States
CHRISTUS Trinity Mother Frances Health SystemNot Yet Recruiting
Tyler, Texas, United States
Centra Health, Inc. dba Stroobants Cardiovascular CenterRecruiting
Lynchburg, Virginia, United States
PeaceHealth Southwest Medical CenterNot Yet Recruiting
Vancouver, Washington, United States
Advocate Aurora Health-St. LukesNot Yet Recruiting
Milwaukee, Wisconsin, United States
CCM OPEN HF Registry · TrialPath