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
Assess 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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Cardiovascular Associates of Mesa
Mesa, Arizona, United States
RECRUITINGUniversity of Arizona and Banner University Medical Center Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGHonorHealth Research Institute
Phoenix, Arizona, United States
NOT_YET_RECRUITINGPeak Heart and Vascular
Surprise, Arizona, United States
RECRUITINGAdventHealth Orlando
Orlando, Florida, United States
NOT_YET_RECRUITINGAdventHealth Tampa
Tampa, Florida, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGHenry Ford Providence Hospital
Novi, Michigan, United States
NOT_YET_RECRUITING...and 18 more locations
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