CCM OPEN HF Registry (CCM OPEN HF)

April 20, 2026 updated by: Impulse Dynamics

CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Cardiovascular Associates of Mesa
        • Principal Investigator:
          • Ambrose Panico, DO
        • Contact:
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • University of Arizona and Banner University Medical Center Phoenix
        • Contact:
        • Contact:
        • Principal Investigator:
          • Preeneth Katrapati, MD
        • Sub-Investigator:
          • Marc Silver, MD
      • Phoenix, Arizona, United States, 85020
        • Not yet recruiting
        • HonorHealth Research Institute
        • Contact:
        • Principal Investigator:
          • Yoavv Krauthammet, MD
      • Surprise, Arizona, United States, 85378
        • Recruiting
        • Peak Heart and Vascular
        • Principal Investigator:
          • Andy Tran, MD
        • Contact:
        • Sub-Investigator:
          • Truong Duong, MD
    • Florida
      • Orlando, Florida, United States, 32803
      • Tampa, Florida, United States, 33613
        • Not yet recruiting
        • AdventHealth Tampa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenneth Yamamura, MD
        • Sub-Investigator:
          • Paul Gerczuk, MD
        • Sub-Investigator:
          • Alejandra Michel, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Hirak Shah, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02144
        • Recruiting
        • Massachusetts General Hospital
        • Sub-Investigator:
          • Kevin Heist, MD
        • Principal Investigator:
          • Theofanie Mela, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jagmeet Singh, MD
        • Sub-Investigator:
          • Dingxin Qin, MD
        • Sub-Investigator:
          • Aneesh Bapat, MD
        • Sub-Investigator:
          • Bill Hucker, MD
        • Sub-Investigator:
          • A Abdul, MD
        • Sub-Investigator:
          • Eric Mills, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • University of Michigan
        • Principal Investigator:
          • Mamid Ghanbari, MD
        • Sub-Investigator:
          • Kirsta Bray, MD
        • Sub-Investigator:
          • Ian Pizzo, MD
      • Novi, Michigan, United States, 48374
        • Not yet recruiting
        • Henry Ford Providence Hospital
        • Principal Investigator:
          • Nathan Foster, MD
        • Contact:
      • Ypsilanti, Michigan, United States, 48197
        • Not yet recruiting
        • Trinity Ann Arbor d/b/a Michigan Heart Ann Arbor
        • Contact:
        • Principal Investigator:
          • Jihn Han, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Not yet recruiting
        • Minneapolis Heart Institute Research Foundation
        • Principal Investigator:
          • Jay Sengupta, MD
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Not yet recruiting
        • Saint Luke's Hospital of Kansas City
        • Principal Investigator:
          • Timothy Fendler, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Daniel Steinhaus, MD
        • Sub-Investigator:
          • Sanjaya Gupta, MD
        • Sub-Investigator:
          • Jose Aguilera, MD
      • Kansas City, Missouri, United States, 64111
        • Not yet recruiting
        • Saint Luke's Hospital Mid America Heart Institute
        • Principal Investigator:
          • Daniel Steinhaus, MD
        • Contact:
        • Contact:
    • New Hampshire
      • Londonderry, New Hampshire, United States, 03053
        • Not yet recruiting
        • Cardiovascular Specialists of New England Research Foundation
        • Contact:
        • Principal Investigator:
          • David Chang, MD
        • Sub-Investigator:
          • Jamie Kim, MD
        • Sub-Investigator:
          • Jinu John, MD
        • Sub-Investigator:
          • Jeanney Lew, MD
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Not yet recruiting
        • Deborah Heart and Lung Center
        • Principal Investigator:
          • Raffaele Corbisiero, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • G Rojas-Marte, MD
        • Sub-Investigator:
          • J Krathen, DO
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Sameer Jamal, MD
        • Contact:
        • Contact:
      • Newark, New Jersey, United States, 07103
        • Not yet recruiting
        • Rutgers New Jersey Medical School & University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amed Aziz, MD
        • Sub-Investigator:
          • Pallavi Solanski, MD
        • Sub-Investigator:
          • Luka Petrovic, MD
    • Oregon
      • Portland, Oregon, United States, 97225
        • Not yet recruiting
        • Providence St. Vincent Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joshua Remick, MD
        • Sub-Investigator:
          • Alexi Zemsky, MD
      • Portland, Oregon, United States, 98686
        • Not yet recruiting
        • Legacy Medical Group Cardiology
        • Contact:
        • Principal Investigator:
          • Brendan Daly, MD
        • Sub-Investigator:
          • Robert Murdock, MD
    • Pennsylvania
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The Stern Cardiovascular Foundation, Inc
        • Contact:
        • Principal Investigator:
          • Steven Gubin, MD
        • Sub-Investigator:
          • Eric Johnson, MD
        • Sub-Investigator:
          • David Lan, MD
    • Texas
      • El Paso, Texas, United States, 79905
        • Recruiting
        • David Turbay, MD
        • Principal Investigator:
          • David Turbay, MD
        • Contact:
      • El Paso, Texas, United States, 79936
        • Not yet recruiting
        • Texan Cardiovascular Institute
        • Principal Investigator:
          • Ali Nasur, MD
        • Contact:
      • Tyler, Texas, United States, 75701
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Centra Health, Inc. dba Stroobants Cardiovascular Center
        • Principal Investigator:
          • Matthew Sackett, MD
        • Contact:
    • Washington
      • Vancouver, Washington, United States, 98644
        • Not yet recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joshua Grant, MD
        • Sub-Investigator:
          • Madhan Nellaiyappan, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Not yet recruiting
        • Advocate Aurora Health-St. Lukes
        • Principal Investigator:
          • Imran Niazi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations
Time Frame: 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.
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess CCM's effect on clinical outcomes
Time Frame: 5 Years
Composite of all-cause mortality, heart-failure hospitalizations/urgent heart failure visits, progression to LVAD/heart transplant 1-, 3-, and 5-years following the index procedure.
5 Years
Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related)
Time Frame: 5 Year

All-cause: Observed mortality will be compared to predicted mortality for the subject group according to the Seattle Heart Failure Model (SHFM) and/or Meta-analysis Global Group in Chronic Heart Failure (MAGGIC) at 1-, 3-, and 5-years following the index procedure.

Cardiovascular related mortality will be assessed at 1-, 3-, and 5-years following the index procedure.
5 Year
Assess CCM's effect on healthy days at home (HDAH)
Time Frame: 3 Years
Assessment of HDAH 1 year prior to 3 years following index implantation.
3 Years
Assess CCM's effect on functional capacity
Time Frame: 5 Year

Change in NYHA Functional Class from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.

Change in 6-minute walk test (6MWT) from baseline to 1 year following the index procedure.
5 Year
Assess CCM's effect cardiovascular reverse remodeling
Time Frame: 5 Year
Change in LVEF, LVESV, LVEDV from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
5 Year
Assess CCM's effect QRS duration
Time Frame: 5 Years
Change in QRS duration from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
5 Years
Assess CCM's systemic effects
Time Frame: 5 Years
Change in eGFR and BNP from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
5 Years
Assess long-term CCM device-related adverse events and lead related events
Time Frame: 5 Years
An assessment of the incidence of CCM device-related serious complications and non-serious CCM-device-related observations occurring during the 5-year period following the index procedure.
5 Years
Assess the dose response of CCM therapy
Time Frame: 5 Year
Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status
5 Year
Evaluate subject battery charging compliance
Time Frame: 5 Year
Assess overall battery charging compliance defined as 60 minutes of charging per 10-day period between charging sessions (Expressed as percentage of compliant charging periods per subject over time e.g., number of compliant charging cycles ÷ total expected cycles × 100%).
5 Year
Assess the effect of ancillary equipment on clinical outcomes
Time Frame: 5 Years

Impact of ancillary equipment on clinical outcomes at 1- 2-, 3-, 4-, and 5-years following the index procedure. Including but not limited to:

Lead type: style-driven lead, lumenless lead

Guiding sheath/catheter
5 Years
Assess CCM clinical outcomes by subject sub-groups
Time Frame: 5 Years

Assess CCM effectiveness at various timepoints in sub-groups of interest, including but not limited to:

Male vs female <65 vs ≥ 65-year-old Ischemic vs non-ischemic CRT non-responders Patients with concomitant devices (e.g. CRT, pacemaker, LBBP) Patients with wide, intermediate, narrow QRS Patients with cardiac amyloidosis
5 Years
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 1 Year
Change in KCCQ score from baseline to 6 months and 1 year after the index procedure. Scores range from 0 to 100, with higher scores showing better health status and lower scores showing worsen health status.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impulse Dynamics

Investigators

  • Study Director: Anthony Hong, Impulse Dynamics
  • Study Director: Lee Ming Boo, Impulse Dynamics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

August 15, 2035

Study Completion (Estimated)

August 1, 2036

Study Registration Dates

First Submitted

August 1, 2025

First Submitted That Met QC Criteria

August 1, 2025

First Posted (Actual)

August 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEN_CA_CP_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data are part of an ongoing commercial development program and are considered proprietary at this stage.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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