Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C

NCT ID: NCT01381172

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2019-03-19

Brief Summary

The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.

Detailed Description

The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER System in patients with NYHA class III and IV heart failure and an ejection fraction 25-45%. The study will involve the recruitment of 160 subjects at a total of up to 60 sites.

Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomly assigned in a 1:1 ratio to either the OPTIMIZER System plus optimal medical therapy (OMT) or to a control group receiving OMT alone. All randomized subjects will be followed for 24 weeks and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive OMT for the treatment of their heart failure. Mortality will be reported out to 2 years.

Conditions

NYHA Class III Heart Failure; NYHA Class IV Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.

Group Type: EXPERIMENTAL

Optimizer System

Intervention Type: DEVICE

The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.

Control

The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.

Group Type: OTHER

No intervention: Optimal medical therapy

Intervention Type: OTHER

The control group receives optimal medical therapy only.

Interventions

Optimizer System

The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.

Intervention Type: DEVICE

No intervention: Optimal medical therapy

The control group receives optimal medical therapy only.

Intervention Type: OTHER

Other Intervention Names

CCM therapy

Eligibility Criteria

Inclusion Criteria

1. Subjects who are 18 years of age or older

2. Subjects who are either male or female. Females of childbearing potential must be using a medically approved method of birth control and must agree to continue to use birth control throughout the study, or must be surgically sterilized (tubal ligation, hysterectomy) or post-menopausal for at least 1 year.

3. Condition

1. Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.

2. Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.

3. Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to the region- specific guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.

4. Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice ), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device or agree to undergo implantation of such a device unless the patient refuses to undergo the implantation of such device for personal reasons.

5. Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria

1. Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg.

2. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.

3. Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.

4. Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.

5. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.

6. Subjects having a PR interval greater than 375 ms.

7. Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.

8. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.

9. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.

10. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.

11. Subjects who have had a myocardial infarction within 90 days of enrollment.

12. Subjects who have mechanical tricuspid valve.

13. Subjects who have a prior heart transplant.

14. Subjects on dialysis.

15. Subjects who are participating in another experimental protocol.

16. Subjects who are unable to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Impulse Dynamics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Burkhoff, MD, PhD

Role: STUDY_DIRECTOR

Impulse Dynamics

Locations

Cardiovascular Consultants

Glendale, Arizona, United States

Cardiovascular Associates of Mesa

Mesa, Arizona, United States

Chan Heart Rhythm Institute

Mesa, Arizona, United States

Arizona Heart & Rhythm Center

Phoenix, Arizona, United States

Pima Heart

Tucson, Arizona, United States

University of Arizona Sarver Heart Center

Tucson, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Yale - New Haven Hospital

New Haven, Connecticut, United States

Florida Hospital

Orlando, Florida, United States

Florida Hospital - Pepin Heart Institute

Tampa, Florida, United States

Advocate Medical Group - Midwest Heart Foundation

Naperville, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Ochsner Clinic

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Detroit Medical Center - Cardiovascular Institute

Detroit, Michigan, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Bryan Heart LGH

Lincoln, Nebraska, United States

UMDNJ

Newark, New Jersey, United States

Mt. Sinai Medical Center

New York, New York, United States

The Lindner Center

Cincinnati, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Guthrie Medical Group

Sayre, Pennsylvania, United States

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Dallas VA Medical Center

Dallas, Texas, United States

Trinity Clinic

Tyler, Texas, United States

Inova Heart & Vascular Institute

Falls Church, Virginia, United States

Aurora Health Care

Milwaukee, Wisconsin, United States

Na Homolce Hospital

Prague, , Czechia

Universitätsmedizin Göttingen

Hanover, Göttingen, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, , Germany

Charité Berlin - Campus Benjamin Franklin

Berlin, , Germany

Charité Campus-Virchow-Klinikum

Berlin, , Germany

ASKLEPIOS Klinik St. Georg

Hamburg, , Germany

UKE - Universitäres Herzzentrum GmbH

Hamburg, , Germany

Universitätsmedizin Mannheim

Mannheim, , Germany

Klinikum der Univ. München - Grosshadern

München, , Germany

Countries

United States; Czechia; Germany

References

Kadish A, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Abraham WT. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J. 2011 Feb;161(2):329-337.e1-2. doi: 10.1016/j.ahj.2010.10.025.

Reference Type: BACKGROUND

PMID: 21315216 (View on PubMed)

Abraham WT, Burkhoff D, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, Kadish A; FIX-HF-5 Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.

Reference Type: BACKGROUND

PMID: 18926146 (View on PubMed)

Neelagaru SB, Sanchez JE, Lau SK, Greenberg SM, Raval NY, Worley S, Kalman J, Merliss AD, Krueger S, Wood M, Wish M, Burkhoff D, Nademanee K. Nonexcitatory, cardiac contractility modulation electrical impulses: feasibility study for advanced heart failure in patients with normal QRS duration. Heart Rhythm. 2006 Oct;3(10):1140-7. doi: 10.1016/j.hrthm.2006.06.031. Epub 2006 Jul 8.

Reference Type: BACKGROUND

PMID: 17018340 (View on PubMed)

Abraham WT, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Kadish A; FIX-HF-5 Investigators and Coordinators. Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. J Card Fail. 2011 Sep;17(9):710-7. doi: 10.1016/j.cardfail.2011.05.006. Epub 2011 Jun 22.

Reference Type: BACKGROUND

PMID: 21872139 (View on PubMed)

Abraham WT, Lindenfeld J, Reddy VY, Hasenfuss G, Kuck KH, Boscardin J, Gibbons R, Burkhoff D; FIX-HF-5C Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: study rationale and design. J Card Fail. 2015 Jan;21(1):16-23. doi: 10.1016/j.cardfail.2014.09.011. Epub 2014 Oct 5.

Reference Type: BACKGROUND

PMID: 25285748 (View on PubMed)

Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10.

Reference Type: BACKGROUND

PMID: 29754812 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

http://www.impulse-dynamics.com/us/

Impulse Dynamics Website

Other Identifiers

G030099

Identifier Type: OTHER

Identifier Source: secondary_id

CP OPT2009-009

Identifier Type: -

Identifier Source: org_study_id