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Assessment of Combined CCM and ICD Device in HFrEF
NCT05855135 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
Conditions Studied
Interventions
- DEVICE OPTIMIZER® Integra CCM-D System (Treatment Arm)
Study Locations (20)
Arizona
- Phoenix Heart — Glendale
- CardioVascular Associates of Mesa — Mesa
- Southwest Cardiovascular Associates — Mesa
- Arizona Heart Rhythm — Phoenix
- CVC Cardiovascular Consultants — Phoenix
- Phoenix Heart — Phoenix
- Honor Health — Scottsdale
Florida
- Broward Health Medical Center — Fort Lauderdale
- Baptist Health South Florida — Miami
- Mount Sinai Medical Center Miami Beach — Miami Beach
- Advent Health Orlando — Orlando
- Cleveland Clinic Weston — Weston
California
- University of Southern California — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
Colorado
- Aurora Denver Cardiology Associates — Aurora
Connecticut
- Hartford HealthCare — Hartford
Iowa
- Iowa Heart Center — West Des Moines
Kansas
- University of Kansas Medical Center — Kansas City
Kentucky
- Baptist Health Lexington — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2027-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05855135
The ClinicalTrials.gov registry entry for NCT05855135 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Impulse Dynamics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which OPTIMIZER® Integra CCM-D System (Treatment Arm) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05855135 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Arizona, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05855135 about?
NCT05855135 is a clinical study titled "Assessment of Combined CCM and ICD Device in HFrEF". The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or ...
What is the current status of trial NCT05855135?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-05-17. Estimated completion is 2027-07.
What conditions does trial NCT05855135 study?
This clinical trial studies the following conditions: Heart Failure, Ventricular Tachycardia, Heart Failure With Reduced Ejection Fraction, Arrhythmias, Cardiac, Ischemic Cardiomyopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05855135?
The interventions under investigation include: OPTIMIZER® Integra CCM-D System (Treatment Arm) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05855135?
This trial is sponsored by Impulse Dynamics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05855135 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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