Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05855135 · ClinicalTrials.gov registry record · NA
Assessment of Combined CCM and ICD Device in HFrEF
A NA study of Heart Failure and Ventricular Tachycardia, sponsored by Impulse Dynamics.
- Active
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05855135: Active NA study of Heart Failure and Ventricular Tachycardia, sponsored by Impulse Dynamics.
NCT05855135 is a NA study of Heart Failure and Ventricular Tachycardia that is active but no longer recruiting, run by Impulse Dynamics. The registered enrollment target is 300 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05855135, a NA study of Heart Failure and Ventricular Tachycardia, is active but no longer recruiting, sponsored by Impulse Dynamics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Evaluate the device effectiveness in converting induced VF at the time of implantation.
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 |
What the registry record for NCT05855135 still lists
NCT05855135 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower).
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.
NCT05855135 names 20 study sites across 9 states, led by Arizona, Florida, California.
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.
What interventions are being tested in trial NCT05855135?
The interventions under investigation include: OPTIMIZER® Integra CCM-D System (Treatment Arm) (DEVICE).
Who is sponsoring clinical trial NCT05855135?
This trial is sponsored by Impulse Dynamics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05855135's enrollment target sits among peer trials
300 138th of 397 higher than 253 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
RECRUITING · NA
-
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
RECRUITING · NA
-
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
RECRUITING · NA
-
Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver
RECRUITING · NA
-
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
RECRUITING · NA
-
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI