CCM OPEN HF Registry

NCT07112924 · tracked via the Priya Life Science USA tracker

Sponsor

Impulse Dynamics

Phase

Observational

Started

2025-11-01

Last updated

2026-04-23

Condition(s) studied

Heart Failure

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations — 1 Year
Change in the HF hospitalization / urgent HF visit rate and hospital length of stay from 1 year prior to 1 year following index implantation.
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
Rate of freedom from a composite of device- or procedure-related complication post-index implantation procedure. Serious procedure related complications occurring through the end of 30 days following the index procedure. Serious CCM device-related complications\* occurring through the end of 1-year following the index procedure. \* excluding lead-related complications

Trial sites (28)

Facility	City	Region	Status
Cardiovascular Associates of Mesa	Mesa	Arizona	Recruiting
University of Arizona and Banner University Medical Center Phoenix	Phoenix	Arizona	Not Yet Recruiting
HonorHealth Research Institute	Phoenix	Arizona	Not Yet Recruiting
Peak Heart and Vascular	Surprise	Arizona	Recruiting
AdventHealth Orlando	Orlando	Florida	Not Yet Recruiting
AdventHealth Tampa	Tampa	Florida	Not Yet Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Not Yet Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
University of Michigan	Ann Arbor	Michigan	Not Yet Recruiting
Henry Ford Providence Hospital	Novi	Michigan	Not Yet Recruiting
Trinity Ann Arbor d/b/a Michigan Heart Ann Arbor	Ypsilanti	Michigan	Not Yet Recruiting
Minneapolis Heart Institute Research Foundation	Minneapolis	Minnesota	Not Yet Recruiting
Saint Luke's Hospital Mid America Heart Institute	Kansas City	Missouri	Not Yet Recruiting
Saint Luke's Hospital of Kansas City	Kansas City	Missouri	Not Yet Recruiting
Cardiovascular Specialists of New England Research Foundation	Londonderry	New Hampshire	Not Yet Recruiting
Deborah Heart and Lung Center	Browns Mills	New Jersey	Not Yet Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	Not Yet Recruiting
Rutgers New Jersey Medical School & University Hospital	Newark	New Jersey	Not Yet Recruiting
Providence St. Vincent Medical Center	Portland	Oregon	Not Yet Recruiting
Legacy Medical Group Cardiology	Portland	Oregon	Not Yet Recruiting
Reading Hospital	West Reading	Pennsylvania	Not Yet Recruiting
The Stern Cardiovascular Foundation, Inc	Germantown	Tennessee	Recruiting
David Turbay, MD	El Paso	Texas	Recruiting
Texan Cardiovascular Institute	El Paso	Texas	Not Yet Recruiting
CHRISTUS Trinity Mother Frances Health System	Tyler	Texas	Not Yet Recruiting
Centra Health, Inc. dba Stroobants Cardiovascular Center	Lynchburg	Virginia	Recruiting
PeaceHealth Southwest Medical Center	Vancouver	Washington	Not Yet Recruiting
Advocate Aurora Health-St. Lukes	Milwaukee	Wisconsin	Not Yet Recruiting

More Impulse Dynamics trials in the USA

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure Recruiting

Assessment of Combined CCM and ICD Device in HFrEF Active, not recruiting

Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy Active, not recruiting

Assessment of CCM in HF With Higher Ejection Fraction Recruiting

Other trials for the same condition

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study) Enrolling by invitation

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure Recruiting

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112924 on ClinicalTrials.gov ↗ ← All trials in the USA