Heart FailureCCM OPEN HFNCT07112924
CCM OPEN HF Registry
An observational study of Heart Failure, run by Impulse Dynamics at 30 sites in United States.
Trial summary
The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 5,500 participants
- Where
- 30 sitesUnited States
- Study dates
- 1 Nov 2025to 1 Aug 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will receive/have received CCM therapy with an Impulse Dynamics system
Who may be able to join
- 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)
Who cannot join
- Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
- Subjects with a mechanical tricuspid valve
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 30 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Mamid Ghanbari, MD
Kirsta Bray, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02144
Payton Black, 617-643-1972, pblack3@mgh.harvard.edu
Chris Azzam, 617-643-9621, cazzam@mgh.harvard.edu
- Not yet recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Lout Lewis, 609-893-1200 ext. 5022, LewisL@Deborah.org
Andrew McElvarr, 609-893-1200 ext. 5016, Mcelavarra@deborah.org
- Recruiting
David Turbay, MD
El Paso, Texas, 79905
Ricardo Pulido, 915-600-2190, rpulido@davidturbaymd.com
David Turbay, MD
- Not yet recruiting
Texan Cardiovascular Institute
El Paso, Texas, 79936
Christy Willis, 915-244-4344, ChristyWillis@TexanASC.com
Ali Nasur, MD
- Recruiting
The Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, 38138
Kari Fondren, 901-271-4062, kari.fondren@sterncardio.com
Steven Gubin, MD
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Manuel Castillo, 551-996-4451, manuel.castillo@hmhn.org
Brandon Palmer, 551-996-4451, brandon.palmer@hmhn.org
- Recruiting
Heart House
Haddon Heights, New Jersey, 08035
Elizabeth Watson, 856-546-3003 ext. 3246, ewatson@hearthousenj.com
Ann Davison, 856-546-3003 ext. 3247, adavison@hearthousenj.com
- Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Quratulain Mushtaq, 913-945-6488, qmushtaq@kumc.edu
Denetta Nelson, 913-588-9679, dnelson14@kumc.edu
- Not yet recruiting
Saint Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, 64111
Caroline Murray, 816-932-2057, ckempter@saint-lukes.org
Sarah Waschow, 816-932-9811, swaschow@saint-lukes.org
- Not yet recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Kendra Black, 816-932-0394, ktraylor@saint-lukes.org
Amada Huffman, 816-932-0391, ahuffman@saint-lukes.org
- Recruiting
Cardiovascular Specialists of New England Research Foundation
Londonderry, New Hampshire, 03053
Jennifer Driscoll, 603-323-0883, jennifer.driscoll@csofne.com
David Chang, MD
- Recruiting
Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
Cindy Baumann, 434-200-2727, cindy.baumann@centrahealth.com
Matthew Sackett, MD
- Recruiting
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206
Adam Gitkin, MS, 480-641-5400, agitkin@cvam.com
Ambrose Panico, DO
- Not yet recruiting
Advocate Aurora Health-St. Lukes
Milwaukee, Wisconsin, 53215
Rebecca Hough, 262-248-5430, rebecca.hough@aah.org
Imran Niazi, MD
- Not yet recruiting
Minneapolis Heart Institute Research Foundation
Minneapolis, Minnesota, 55407
Jilianne Feola, julianne.feola@allina.com
Jay Sengupta, MD
- Not yet recruiting
Rutgers New Jersey Medical School & University Hospital
Newark, New Jersey, 07103
Adel Aly, 973-972-1054, aaa531@njms.rutgers.edu
Hector Salcedo, hrs60@njms.rutgers.edu
- Not yet recruiting
Henry Ford Providence Hospital
Novi, Michigan, 48374
Candice Edillo, 248-849-3197, cedillo1@hfhs.org
Nathan Foster, MD
- Recruiting
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
Rebecca Straily, 405-608-1287, rstraily@okheart.com
Charles Te, MD
- Not yet recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Jennifer Lyden, 407-303-7556, jennifer.lyden@adventhealth.com
Chantie Garvey, 407-303-7556, chantie.garvey@adventhealth.com
- Not yet recruiting
University of Arizona and Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Sydney Mintalar, 612-408-3573, smintalar@arizona.edu
Abisola Akinbobola, 706-308-5892, abisola.akinbobola@bannerhealth.com
- Not yet recruiting
HonorHealth Research Institute
Phoenix, Arizona, 85020
Kevin Stone, 570-370-8023, kestone@honorhealth.com
Yoavv Krauthammet, MD
- Not yet recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Sarah Jackson, 503-216-7370, Sarah.Jackson3@providence.org
Marcia Macsisak, 503-216-7195, Marcia.Macsisak@providence.org
- Not yet recruiting
Legacy Medical Group Cardiology
Portland, Oregon, 98686
Kristin Hickey, 503-413-4365, khickey@lhs.org
Brendan Daly, MD
- Recruiting
Peak Heart and Vascular
Surprise, Arizona, 85378
Neha Joshi, 602-830-2626, njoshi@onyxclinical.com
Andy Tran, MD
- Not yet recruiting
AdventHealth Tampa
Tampa, Florida, 33613
Cynthia Paysor, 813-610-8110, cynthia.paysor@adventhealth.com
Gerardo Bustos, 813-610-8110, gerardo.bustos@adventhealth.com
- Recruiting
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
Susan Stocks, 903-606-1621, susan.stocks@christushealth.org
Jamie Wylie, 903-606-3737, jamiecrystal.wylie@christushealth.org
- Not yet recruiting
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98644
May E Peggy Lau, 360-514-2154, plau@peacehealth.org
Kara Makin-Bond, 360-514-3940, KMakin-bond@peacehealth.org
- Not yet recruiting
Reading Hospital
West Reading, Pennsylvania, 19611
Mary Aldenfer, mary.alderfer@towerhealth.org
Pamela Marrero, Pamela.marrero@towerhealth.org
- Not yet recruiting
Trinity Ann Arbor d/b/a Michigan Heart Ann Arbor
Ypsilanti, Michigan, 48197
Autumn Howe, 734-712-8387, ahowe@michiganheart.com
Jihn Han, MD
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 Years
Secondary outcomes (13)
Assess CCM's effect on clinical outcomes
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.
Measured: 5 Years
Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related)
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.
Measured: 5 Year
Assess CCM's effect on healthy days at home (HDAH)
Assessment of HDAH 1 year prior to 3 years following index implantation.
Measured: 3 Years
Assess CCM's effect on functional capacity
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.
Measured: 5 Year
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: 1 Year
Assess CCM's effect cardiovascular reverse remodeling
Change in LVEF, LVESV, LVEDV from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
Measured: 5 Year
Assess CCM's effect QRS duration
Change in QRS duration from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
Measured: 5 Years
Assess CCM's systemic effects
Change in eGFR and BNP from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.
Measured: 5 Years
Assess long-term CCM device-related adverse events and lead related events
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.
Measured: 5 Years
Assess the dose response of CCM therapy
Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status
Measured: 5 Year
Evaluate subject battery charging compliance
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%).
Measured: 5 Year
Assess the effect of ancillary equipment on clinical outcomes
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
Measured: 5 Years
Assess CCM clinical outcomes by subject sub-groups
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
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Nov 2025
- Primary completion15 Aug 2035 (estimated)
- Study completion1 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Hong, Study director, Impulse DynamicsLee Ming Boo, Study director, Impulse Dynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112924
- Sponsor's protocol ID
- OPEN_CA_CP_2025
- Acronym
- CCM OPEN HF
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are part of an ongoing commercial development program and are considered proprietary at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure
- ClinicalTrials.gov ID
- NCT07112924
- Acronym / sponsor ID
- CCM OPEN HF / OPEN_CA_CP_2025
- Conditions
- Heart Failure
- Keywords
- Heart Failure, CCM, Optimizer, Implantable Pulse Generator, FDA Approved, Heart Failure Hospitalization, Ischemic vs non-ischemic, CRT non-responders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Aug 2035 (estimated)
- Study completion
- 1 Aug 2036 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will receive/have received CCM therapy with an Impulse Dynamics system
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
- Subjects with a mechanical tricuspid valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
13 secondary outcomes
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
Assess CCM clinical outcomes by subject sub-groups
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Sponsor of CCM StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data are part of an ongoing commercial development program and are considered proprietary at this stage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Hong study director
Impulse Dynamics
Lee Ming Boo study director
Impulse Dynamics
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Impulse Dynamics at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Van Wygerden (856-642-9933, kvanwygerden@impulsedynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.