Heart Failure and Reduced Ejection FractionBRIGHTEN-HFNCT07209098
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
An observational study of Heart Failure and Reduced Ejection Fraction and NYHA Class III Heart Failure, run by Impulse Dynamics at 1 site in United States.
Trial summary
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction, NYHA Class III Heart Failure
- What is being tested?
- Cardiac Contractility Modulation (CCM)
- Type of treatment
- Medical device
- How many people
- 4,200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to Apr 2031
- 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: Participants are patients with heart failure who are identified from a large, de-identified, multi-system electronic health record (EHR) database representing diverse healthcare settings across the United States. The database includes patients receiving care in hospitals, outpatient clinics, and other sites where cardiac contractility modulation (CCM) therapy is delivered. The population reflects typical sites of CCM implantation in Medicare-eligible adults across multiple states and integrated delivery networks (IDNs).
Who may be able to join
- Continuous representation in the database in the year prior to index.
- Age 18 or older will be enrolled in either the treatment or control arm of the study.
- NYHA III heart failure,
- Not receiving CRT
- EF 25 - 45%, inclusive.
- Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation.
Who cannot join
- Subject has had a prior heart transplant
- Subject with mechanical tricuspid valve.
- Subject has a left ventricular assist device (LVAD).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Impulse Dynamics
Marlton, New Jersey, 08053
Kathy Sherwood, MBA, 856-642-9933, ksherwood@impulsedynamics.com
About this study
Official title: Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.
Read the detailed description
Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from multiple U.S. healthcare systems. The database includes demographics, clinical notes, imaging, laboratory results, medications, social determinants of health, and other relevant healthcare information, with up to 8 years of historical clinical data updated regularly.
- Being tested
- Cardiac Contractility Modulation (CCM)
- Keywords
- Heart failure, Reduced ejection fraction, Cardiac Contractility Modulation, CCM, NYHA III, Propensity Score Matching, All-Cause Mortality, Heart Failure Hospitalizations, CED
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Contractility Modulation (CCM)Device
CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System. Receives: Device: Cardiac Contractility Modulation (CCM) | |
| Control Group | The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first heart failure hospitalization or all-cause death
Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.
Measured: Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start18 Nov 2025
- Primary completionOct 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies 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
- Prospective
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209098
- Sponsor's protocol ID
- CA_CP_2558
- Acronym
- BRIGHTEN-HF
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broaden Accessibility of Breakthrough Treatment for Heart Failure: A Prospective, Propensity-Matched CED to Access the Impact of Cardiac Contractility Modulation Therapy (CCM)
- ClinicalTrials.gov ID
- NCT07209098
- Acronym / sponsor ID
- BRIGHTEN-HF / CA_CP_2558
- Keywords
- Heart failure, Reduced ejection fraction, Cardiac Contractility Modulation, CCM, NYHA III, Propensity Score Matching, All-Cause Mortality, Heart Failure Hospitalizations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 6 Oct 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 purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.
Detailed description
Data for both the CCM treatment arm and a propensity-matched control group come from a large, de-identified, aggregated electronic health record (EHR) database containing patient information from multiple U.S. healthcare systems. The database includes demographics, clinical notes, imaging, laboratory results, medications, social determinants of health, and other relevant healthcare information, with up to 8 years of historical clinical data updated regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Cardiac Contractility Modulation (CCM)Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System. |
| Control Group | – | –The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patients with heart failure who are identified from a large, de-identified, multi-system electronic health record (EHR) database representing diverse healthcare settings across the United States. The database includes patients receiving care in hospitals, outpatient clinics, and other sites where cardiac contractility modulation (CCM) therapy is delivered. The population reflects typical sites of CCM implantation in Medicare-eligible adults across multiple states and integrated delivery networks (IDNs).
Key inclusion criteria (6 listed)
- Continuous representation in the database in the year prior to index.
- Age 18 or older will be enrolled in either the treatment or control arm of the study.
- NYHA III heart failure,
- Not receiving CRT
- EF 25 - 45%, inclusive.
Key exclusion criteria (3 listed)
- Subject has had a prior heart transplant
- Subject with mechanical tricuspid valve.
- Subject has a left ventricular assist device (LVAD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Contractility Modulation (CCM)CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption. | Device | Treatment Group |
Primary outcome
Time to first heart failure hospitalization or all-cause death
Time frame: Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.
Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.
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 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 and Reduced Ejection Fraction and NYHA Class III Heart Failure, run by Impulse Dynamics at 1 site 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 6 inclusion and 3 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kathy Sherwood, MBA (856-642-9933, ksherwood@impulsedynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first heart failure hospitalization or all-cause death (time frame: Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.). 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 24 Mar 2026.