Trial · NCT07112924
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Assess long-term CCM device-related adverse events and lead related events | 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. |
| Secondary | Assess the dose response of CCM therapy | 5 Year | Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status |
| Secondary | Evaluate subject battery charging compliance | 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%). |
| Secondary | Assess the effect of ancillary equipment on clinical outcomes | 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 |
| Secondary | Assess CCM clinical outcomes by subject sub-groups | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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