Heart Failure
Conditions
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
Brief summary
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.
Interventions
None listed
Sponsors
Impulse Dynamics
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Assess CCM's effect on healthy days at home (HDAH) | 3 Years | Assessment of HDAH 1 year prior to 3 years following index implantation. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Assess the dose response of CCM therapy | 5 Year | Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status |
| 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%). |
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTKarl Van Wygerden
CONTACTErika Mednick
STUDY_DIRECTORAnthony Hong
Impulse Dynamics
STUDY_DIRECTORLee Ming Boo
Impulse Dynamics
Outcome results
None listed