CCM OPEN HF Registry

NCT07112924 | Recruiting

• 1 other identifier: OPEN_CA_CP_2025
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart Failure; CCM; Optimizer; Implantable Pulse Generator; FDA Approved; Heart Failure Hospitalization; Ischemic vs non-ischemic; CRT non-responders; Patients with concomitant devices; Patients with wide, intermediate, narrow QRS; Patients with cardiac amyloidosis

Outcome Measures

Primary Outcomes (2)

• Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations

  Change in the HF hospitalization / urgent HF visit rate and hospital length of stay from 1 year prior to 1 year following index implantation.

  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.

  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

  5 Years

Secondary Outcomes (13)

• Assess CCM's effect on clinical outcomes

  5 Years

• Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related)

  5 Year

• Assess CCM's effect on healthy days at home (HDAH)

  3 Years

• Assess CCM's effect on functional capacity

  5 Year

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  1 Year

Study Arms (3)

Retrospective Cohort

Prospective Cohort

Hybrid (Retrospective-Prospective) Cohort

Patients who will receive/ have received CCM therapy with an Impulse Dynamics devices

Prospective Cohort

Patients who will receive CCM therapy with an Impulse Dynamics devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will receive/have received CCM therapy with an Impulse Dynamics system

You may qualify if:

• 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)

You may not qualify if:

• Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
• Subjects with a mechanical tricuspid valve

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (28)

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

RECRUITING

University of Arizona and Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

HonorHealth Research Institute

Phoenix, Arizona, 85020, United States

NOT YET RECRUITING

Peak Heart and Vascular

Surprise, Arizona, 85378, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

NOT YET RECRUITING

AdventHealth Tampa

Tampa, Florida, 33613, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Henry Ford Providence Hospital

Novi, Michigan, 48374, United States

NOT YET RECRUITING

Trinity Ann Arbor d/b/a Michigan Heart Ann Arbor

Ypsilanti, Michigan, 48197, United States

NOT YET RECRUITING

Minneapolis Heart Institute Research Foundation

Minneapolis, Minnesota, 55407, United States

NOT YET RECRUITING

Saint Luke's Hospital Mid America Heart Institute

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

NOT YET RECRUITING

Cardiovascular Specialists of New England Research Foundation

Londonderry, New Hampshire, 03053, United States

NOT YET RECRUITING

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

NOT YET RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Rutgers New Jersey Medical School & University Hospital

Newark, New Jersey, 07103, United States

NOT YET RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

NOT YET RECRUITING

Legacy Medical Group Cardiology

Portland, Oregon, 98686, United States

NOT YET RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

NOT YET RECRUITING

The Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, 38138, United States

RECRUITING

David Turbay, MD

El Paso, Texas, 79905, United States

RECRUITING

Texan Cardiovascular Institute

El Paso, Texas, 79936, United States

NOT YET RECRUITING

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

NOT YET RECRUITING

Centra Health, Inc. dba Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States

RECRUITING

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98644, United States

NOT YET RECRUITING

Advocate Aurora Health-St. Lukes

Milwaukee, Wisconsin, 53215, United States

NOT YET RECRUITING

Related Links

• Sponsor of CCM Studies

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Anthony Hong

  Impulse Dynamics

  STUDY DIRECTOR

• Lee Ming Boo

  Impulse Dynamics

  STUDY DIRECTOR

Central Study Contacts

Karl Van Wygerden

CONTACT

856-642-9933; kvanwygerden@impulsedynamics.com

Erika Mednick

CONTACT

8454990412; emednick@impulsedynamics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 15, 2035
• Study Completion (Estimated): August 1, 2036
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)