CCM OPEN HF Registry
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImpulse Dynamics
About this trial
The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators.
Subjects with a mechanical tricuspid valve
Trial population
Patients who will receive/have received CCM therapy with an Impulse Dynamics system
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
5,500 Participants
are grouped into 3 trial groupsGroup A: Retrospective Cohort
Group B: Hybrid (Retrospective-Prospective) Cohort
Group C: Prospective Cohort
Trial outcomes
Primary outcomes
1
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 Year2
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 YearsSecondary outcomes
1
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 Years2
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 Year3
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 Years4
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 YearSponsors and contacts
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Source ClinicalTrials.gov