Trial · NCT07112924
CCM OPEN HF Registry
NCT07112924, Recruiting, Impulse Dynamics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CCM OPEN HF Registry. Trials, record NCT07112924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07112924
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CCM OPEN HF Registry
- NCT number
- NCT07112924
- Status
- Recruiting
- Enrollment
- 5,500 participants, estimated
- Lead sponsor
- Impulse Dynamics
- Conditions
- Heart Failure
- First posted
- 2025-08-08
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 |
| Secondary | Assess CCM's effect on clinical outcomes | 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. |
| Secondary | Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related) | 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. |
| Secondary | Assess CCM's effect on healthy days at home (HDAH) | 3 Years | Assessment of HDAH 1 year prior to 3 years following index implantation. |
| Secondary | Assess CCM's effect on functional capacity | 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. |
| Secondary | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. |
| Secondary | Assess CCM's effect cardiovascular reverse remodeling | 5 Year | Change in LVEF, LVESV, LVEDV from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure. |
| Secondary | Assess CCM's effect QRS duration | 5 Years | Change in QRS duration from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure. |
| Secondary | Assess CCM's systemic effects | 5 Years | Change in eGFR and BNP from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07112924
GET https://conductscience.org/api/trials/v1/NCT07112924/registered