Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Recruiting · NCT07209098 · Observational (researchers observe without assigning treatment) · Lead sponsor: Impulse Dynamics
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac Contractility Modulation (CCM)
What this trial is about
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Continuous representation in the database in the year prior to index.
- Age 18 or older will be enrolled in either the treatment or control arm of the study.
- NYHA III heart failure,
- Not receiving CRT
- EF 25 - 45%, inclusive.
- Remain symptomatic despite at least 3 months of optimized guideline-directed medical therapy (GDMT) as determined by the heart team prior to CCM implantation.
Exclusion criteria
- Subject has had a prior heart transplant
- Subject with mechanical tricuspid valve.
- Subject has a left ventricular assist device (LVAD).
Where it is running
1 location listed across 1 US state.
- Impulse Dynamics - Marlton, New Jersey, United States