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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 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.

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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.

Conditions Studied

Heart Failure Ventricular Tachycardia Heart Failure With Reduced Ejection Fraction Arrhythmias, Cardiac Ischemic Cardiomyopathy Sudden Cardiac Arrest Ventricular Fibrillation Implantable Defibrillator User Non-ischemic Cardiomyopathy CCM Therapy

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

FieldValue
Enrollment Target 300 participants
Start Date 2023-05-17
Est. Completion 2027-07
Phase NA

Sponsor

Impulse Dynamics

9 total trials

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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, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (85% lower). The listed sponsor is Impulse Dynamics, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.