CCM Device for Heart Failure

(INTEGRA-D Trial)

Not currently recruiting at 66 trial locations

Overseen By Gary Cranke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Impulse Dynamics

Must be taking: Guideline-directed therapy

Disqualifiers: Severe AI, AS, MS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the OPTIMIZER® Integra CCM-D System to determine its safety and effectiveness in managing dangerous heart rhythms in individuals with advanced heart failure. The device aims to assist those with reduced heart function who continue to experience symptoms despite standard heart failure treatments. Participants should have heart failure, experience troubling heart rhythms, and not qualify for certain other heart treatments. The trial involves implanting the device and monitoring for complications over at least two years. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options for heart failure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should already be on guideline-directed medical therapy for heart failure, so you may need to continue those medications.

What prior data suggests that the CCM-D System is safe for heart failure patients?

Research has shown that the OPTIMIZER® Integra CCM-D System has been safely implanted and tested in 100 patients. In these tests, the device effectively addressed heart rhythm issues such as ventricular fibrillation, a serious heart problem. This indicates that patients generally tolerate the device well. The FDA has also approved the CCM-D system for treating heart failure, which supports its safety. While all medical procedures carry some risks, current data suggests that this device is generally safe for treating heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPTIMIZER® Integra CCM-D System for heart failure because it introduces a unique approach called cardiac contractility modulation (CCM). Unlike traditional treatments like medications and devices that primarily focus on improving heart pumping efficiency or managing symptoms, the CCM-D device directly enhances the strength of heart contractions by delivering electrical signals to the heart muscle. This novel mechanism could offer a new avenue for patients who do not respond well to existing therapies, potentially improving their quality of life and heart function.

What evidence suggests that the CCM-D System is effective for heart failure?

Studies have shown that the OPTIMIZER® Integra CCM-D System works well for patients with heart failure. In a study with 100 patients, researchers successfully placed the device, and tests confirmed it effectively controlled dangerous heart rhythms. This indicates the device can help manage serious heart issues in people with heart failure. In this trial, participants will receive the CCM-D Implant, which includes cardiac contractility modulation (CCM) therapy, approved by the FDA for treating heart failure. This treatment targets patients whose hearts don't pump effectively, even when they are on regular medication. ^{1 2 3 5 6}

Who Is on the Research Team?

Niraj Varma, MD

Principal Investigator

The Cleveland Clinic

Nir Uriel, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion 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.

You have been recommended to have an implantable cardioverter defibrillator (ICD) because of your heart condition.

I am on standard treatment for heart failure.

Exclusion Criteria

Pregnant or planning to become pregnant during the study

I have not had unstable chest pain in the last 30 days.

You have a mechanical tricuspid valve implanted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Eligible subjects are implanted with the CCM-D System, and a subset is induced into ventricular fibrillation during the procedure

1 day

1 visit (in-person)

Initial Follow-up

Evaluate device-related complications and inappropriate ICD shocks

6 months

Regular visits (in-person and virtual)

Long-term Follow-up

Monitor inappropriate shock rate, device effectiveness, and battery longevity

2 years

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• OPTIMIZER® Integra CCM-D System

Trial Overview 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.

How Is the Trial Designed?

Group I: CCM-D Implant Experimental Treatment 1 Intervention

The subject is implanted with the CCM-D device.

OPTIMIZER® Integra CCM-D System is already approved in United States, European Union for the following indications:

Approved in United States as Optimizer System for:

• Moderate to severe chronic heart failure in patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for cardiac resynchronization therapy, and have a left ventricular ejection fraction ranging from 25 to 45 percent

Approved in European Union as Optimizer System for:

• Moderate to severe chronic heart failure in patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for cardiac resynchronization therapy, and have a left ventricular ejection fraction ranging from 25 to 45 percent

Who Is Running the Clinical Trial?

Impulse Dynamics

Lead Sponsor

Trials

14

Recruited

3,800+

Published Research Related to This Trial

The Optimizer Smart device, which uses cardiac contractility modulation (CCM), is FDA-approved for treating chronic heart failure in patients with a left ventricular ejection fraction (LVEF) between 25% and 45%, offering a new option for those who are symptomatic despite optimal medical therapy.

Clinical trials show that CCM therapy is safe and effective, leading to reduced hospitalizations for heart failure and improved symptoms, quality of life, and functional performance, particularly for patients who do not qualify for traditional cardiac resynchronization therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizer Smart in the treatment of moderate-to-severe chronic heart failure. Campbell, CM., Kahwash, R., Abraham, WT.[2021]

In a study of 70 heart failure patients treated with cardiac contractility modulation (CCM) over an average follow-up of 2.8 years, the QRS duration remained stable, indicating that CCM therapy may prevent the worsening of intra-ventricular conduction associated with heart failure.

Unlike other heart failure treatments that typically show an increase in QRS duration over time, CCM therapy appears to maintain QRS duration, suggesting it may have long-term safety benefits and potentially improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term impact of cardiac contractility modulation on QRS duration. Röger, S., Michels, J., Heggemann, F., et al.[2014]

In a retrospective study of 68 heart failure patients treated with Cardiac Contractility Modulation (CCM), long-term mortality rates were significantly lower than predicted by the Seattle Heart Failure Model, suggesting a potential survival benefit from this treatment.

The study followed patients for an average of 4.5 years, showing that CCM may improve survival outcomes in heart failure patients with NYHA II-III symptoms and a QRS duration of ≤130ms, indicating its efficacy in this specific population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival with Cardiac Contractility Modulation in patients with NYHA II or III symptoms and normal QRS duration. Kloppe, A., Lawo, T., Mijic, D., et al.[2016]

Cardiac contractility modulation (CCM) therapy using the Optimizer Smart System is a new, minimally invasive device therapy for heart failure patients who do not qualify for traditional treatments like cardiac resynchronization therapy (CRT).

Initial findings suggest that CCM therapy is safe and feasible for a broad range of heart failure patients, but further large-scale randomized controlled trials are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy. Chera, HH., Al-Sadawi, M., Michelakis, N., et al.[2021]

Cardiac contractility modulation (CCM) therapy is effective for patients with systolic heart failure, improving peak VO2, quality of life, and exercise tolerance, making it a valuable addition to existing treatments like implantable cardioverter defibrillators (ICDs).

CCM therapy is recommended for symptomatic patients with a left ventricular ejection fraction of 35% or less, but it is contraindicated in those with atrial fibrillation, high-grade arrhythmias, or significant AV block, highlighting the importance of patient selection for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating congestive heart failure with cardiac contractility modulation (CCM) : possibilities and study overview]. Tönnis, T., Kuck, KH.[2021]

Citations

1. tctmd.com tctmd.com/news/ccm-d-delivers-safe-effective-integrated-therapy-hfref

CCM-D Delivers Safe, Effective Integrated Therapy in HFrEF The Optimizer Integra device was successfully implanted and induced in 100 patients, with defibrillation testing resulting in complete success.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05855135

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 ...

3. news.impulse-dynamics.com news.impulse-dynamics.com/impulse-dynamics-integra-d-trial-completes-efficacy-phase/

Impulse Dynamics®' INTEGRA-D Trial Completes Efficacy ... The INTEGRA-D trial is a multicenter, prospective, single-arm study evaluating the safety and efficacy of CCM-D HF System in 300 patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307863/

Cardiac Contractility Modulation for Heart Failure Cardiac contractility modulation (CCM) is a Food and Drug Administration-approved device-based therapy for patients with heart failure.

5. anthem.com anthem.com/medpolicies/abcbs/active/mp_pw_d093234.html

SURG.00153 Cardiac Contractility Modulation Therapy This document addresses the use of cardiac contractility modulation therapy designed to treat chronic moderate-to-severe heart failure.

6. impulse-dynamics.com impulse-dynamics.com/global/impulse-dynamics-announces-first-implant-for-ccm-d-clinical-trial/

Impulse Dynamics Announces First Implant for CCM-D™ ... The study will assess the performance of the CCM-D device in effectively treating episodes of ventricular tachycardia and/or ventricular ...