Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
NCT ID: NCT07209098
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4200 participants
OBSERVATIONAL
2025-11-30
2031-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Group
Treatment patients shall be those with a clinical indication for CCM implantation according to FDA approved labeling and who are implanted with the Optimizer System.
Cardiac Contractility Modulation (CCM)
CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
Control Group
The control group shall be derived from propensity score matching of patients derived from the database with a clinical indication for CCM implantation who do not receive an implant.
No interventions assigned to this group
Interventions
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Cardiac Contractility Modulation (CCM)
CCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 or older will be enrolled in either the treatment or control arm of the study.
3. NYHA III heart failure,
4. Not receiving CRT
5. EF 25 - 45%, inclusive.
6. 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
2. Subject with mechanical tricuspid valve.
3. Subject has a left ventricular assist device (LVAD).
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Responsible Party
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Locations
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Impulse Dynamics
Marlton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CA_CP_2558
Identifier Type: -
Identifier Source: org_study_id
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