The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.
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 Type
OBSERVATIONAL
Enrollment
5,500
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
RECRUITINGAssess 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.
Time frame: 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
Time frame: 5 Years
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.
Time frame: 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.
Time frame: 5 Year
Assess CCM's effect on healthy days at home (HDAH)
Assessment of HDAH 1 year prior to 3 years following index implantation.
Time frame: 3 Years
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 Years
Assess the dose response of CCM therapy
Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status
Time frame: 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%).
Time frame: 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
Time frame: 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
Time frame: 5 Years