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Device
CCM Device for Heart Failure (INTEGRA-D Trial)
N/A
Recruiting
Led By Nir Uriel, MD
Research Sponsored by Impulse Dynamics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is on GDMT for heart failure
Patient is aged 18 years or older
Must not have
End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if a device can safely and effectively treat ventricular fibrillation in people with Stage C or D heart failure.
Who is the study for?
This trial is for adults over 18 with heart failure (HFrEF) and a left ventricular ejection fraction (LVEF) of 40% or less, who are symptomatic despite treatment but don't qualify for cardiac resynchronization therapy. They must not be pregnant, have severe valve disease, unstable angina, other major medical conditions like end-stage renal disease, or be in another device/drug study.
What is being tested?
The OPTIMIZER® Integra CCM-D System is being tested to see if it can safely and effectively manage life-threatening rapid heartbeats in patients with advanced heart failure who aren't candidates for certain other therapies. The system will be implanted and monitored over at least two years.
What are the potential side effects?
Potential side effects may include complications from the implant procedure itself, inappropriate shocks from the device during follow-up period, and any issues related to having an electronic device within the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on standard treatment for heart failure.
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I am 18 years old or older.
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My heart's pumping ability is reduced (LVEF ≤40%).
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My heart failure is classified as Stage C or D.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe kidney disease, am on dialysis, or have a major illness like liver failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ implant to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Device-related Complications (Primary Safety Objective)
Secondary study objectives
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Other study objectives
Battery degradation and longevity
Charging non-compliance
Inappropriate Shock Rate out to 2-years
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CCM-D ImplantExperimental Treatment1 Intervention
The subject is implanted with the CCM-D device.
Find a Location
Who is running the clinical trial?
Impulse DynamicsLead Sponsor
13 Previous Clinical Trials
3,517 Total Patients Enrolled
11 Trials studying Heart Failure
3,315 Patients Enrolled for Heart Failure
Nir Uriel, MDPrincipal InvestigatorColumbia University
5 Previous Clinical Trials
288 Total Patients Enrolled
4 Trials studying Heart Failure
238 Patients Enrolled for Heart Failure
Niraj Varma, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of heart muscle disease and it's been over 40 days since my last heart attack, if I had one.I have not had unstable chest pain in the last 30 days.You have been recommended to have an implantable cardioverter defibrillator (ICD) because of your heart condition.You have a mechanical tricuspid valve implanted.Your heart's PR interval is longer than 375 milliseconds, or you have advanced AV block.I have a severe kidney disease, am on dialysis, or have a major illness like liver failure.I am on standard treatment for heart failure.I am 18 years old or older.My heart's pumping ability is reduced (LVEF ≤40%).I do not have severe aortic or mitral valve issues.I am a candidate for chemoradiotherapy (CRT).I have not had heart surgery in the last 90 days or a stent placement in the last 30 days.You have had a heart transplant or a ventricular assist device in the past.You need a permanent pacemaker for a slow heart rhythm.You have an implanted heart device like a pacemaker or defibrillator.My heart failure is classified as Stage C or D.You have had mitral valve repair or clip surgery in the last 90 days before agreeing to join the study.You are expected to live for more than 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: CCM-D Implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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