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Device
CCM Device for Heart Failure (INTEGRA-D Trial)
N/A
Recruiting
Led By Niraj Varma, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant to 2 years
Awards & highlights
INTEGRA-D Trial 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.Check my eligibility
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.See study design
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.
INTEGRA-D Trial 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.
INTEGRA-D Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Device-related Complications (Primary Safety Objective)
Secondary outcome measures
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Other outcome measures
Battery degradation and longevity
Charging non-compliance
Inappropriate Shock Rate out to 2-years
+1 moreINTEGRA-D 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
12 Previous Clinical Trials
3,615 Total Patients Enrolled
Niraj Varma, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
Nir Uriel, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited for this experiment?
"Affirmative, the clinical trial is currently accepting applicants. This therapy was first posted on May 17th 2023 and has since been updated to reflect its latest changes. The study requires 300 volunteers from 6 sites."
Answered by AI
Are individuals currently being accepted to participate in this research?
"The information hosted on clinicaltrials.gov suggests that this research programme is actively seeking participants, having been posted on May 17th 2023 and updated as recently as July 25th 2023."
Answered by AI
How many research centers are presently conducting this trial?
"This medical trial is being conducted at Honor Health in Scottsdale, Kansas, University of Kansas Medical Center in Kansas City, Ohio and Cleveland Clinic in Cleveland, Pennsylvania. Additionally, 6 other research sites are participating."
Answered by AI
Who else is applying?
What site did they apply to?
Lancaster General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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