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Using a device to treat heart failure and prevent dangerous heart rhythms

Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction

Not applicable Interventional Impulse Dynamics · NCT05855135

This study is testing a new device to see if it can help people with severe heart failure feel better and prevent dangerous heart rhythms.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorImpulse Dynamics Industry-sponsored
Locations63 sites (Glendale, Arizona and 62 other locations)
Trial IDNCT05855135 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the OPTIMIZER® Integra CCM-D System in patients with Stage C or D heart failure who have reduced ejection fraction and remain symptomatic despite standard medical therapy. Participants will receive the device, and a subset will undergo induced ventricular fibrillation during the implantation procedure to assess the device's performance. The study will monitor inappropriate shock rates and device-related complications over a follow-up period of at least two years.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with Stage C or D heart failure, reduced ejection fraction, and who are on guideline-directed medical therapy.

Not a fit: Patients with severe aortic insufficiency or stenosis, or those with certain heart conditions that contraindicate the use of the device may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of heart failure patients at risk of life-threatening arrhythmias.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing heart failure and arrhythmias, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Individuals must meet all the following:

1. Patient is aged 18 years or older;
2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
3. Patient has HFrEF (LVEF ≤40%);
4. Patient is on GDMT for heart failure;
5. Patient has a Class I or Class II indication for an ICD
6. Patient has a reasonable expectation of meaningful survival of \> 1 year;
7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
4. Prior heart transplant or ventricular assist device;
5. Implanted mechanical tricuspid valve;
6. PR interval greater than 375ms or advanced AV block;
7. In situ S-ICD, pacemaker, or CRT device;
8. Indicated for CRT;
9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
10. Indicated for permanent bradyarrhythmia pacing;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Pregnant or planning to become pregnant during the study;
13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Where this trial is running

Glendale, Arizona and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureHeart Failure With Reduced Ejection FractionImplantable Defibrillator UserCCM TherapyNon-ischemic CardiomyopathyIschemic CardiomyopathySudden Cardiac ArrestArrhythmias, Cardiac
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.