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

NCT01381172 | Completed Results DMC

• 2 other identifiers: CP OPT2009-009G030099
• Study Type: interventional
• Target: 160
• Locations: 3 countries
• Sites: 42

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.

Conditions

NYHA Class III Heart Failure; NYHA Class IV Heart Failure

Keywords

Heart Failure; Congestive Heart Failure; Chronic heart disease; Cardiac contractility modulation; CCM; CHF

Outcome Measures

Primary Outcomes (1)

• Peak VO2

  Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX) and evaluated by a blinded core lab.

  24 weeks

Secondary Outcomes (4)

• Minnesota Living With Heart Failure (MLWHF) Questionnaire

  24 weeks

• Peak VO2 With Respiratory Exchange Ratio (RER)

  24 weeks

• NYHA

  24 weeks

• Peak VO2 With a Peak RER of ≥1.05

  24 weeks

Other Outcomes (2)

• 6 Minute Hall Walk

  24 weeks

• VE/VCO2

  24 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: Optimizer System

Control

OTHER

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

Other: No intervention: Optimal medical therapy

Interventions

Optimizer System 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.

Also known as: CCM therapy

Treatment

No intervention: Optimal medical therapy OTHER

The control group receives optimal medical therapy only.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are 18 years of age or older
• 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.
• Condition
• 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.
• 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.
• 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.
• 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.
• Subjects who are willing and able to return for all follow-up visits.

You may not qualify if:

• Subjects whose baseline peak VO2 is \<9 or \>20 ml O2/min/kg.
• Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
• 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.
• Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
• Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
• Subjects having a PR interval greater than 375 ms.
• Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.
• 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.
• 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.
• Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
• Subjects who have had a myocardial infarction within 90 days of enrollment.
• Subjects who have mechanical tricuspid valve.
• Subjects who have a prior heart transplant.
• Subjects on dialysis.
• Subjects who are participating in another experimental protocol.

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (42)

Cardiovascular Consultants

Glendale, Arizona, 85306, United States

Location

Cardiovascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Chan Heart Rhythm Institute

Mesa, Arizona, 85206, United States

Location

Arizona Heart & Rhythm Center

Phoenix, Arizona, 85013, United States

Location

Pima Heart

Tucson, Arizona, 85712, United States

Location

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Yale - New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Florida Hospital - Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Advocate Medical Group - Midwest Heart Foundation

Naperville, Illinois, 60540, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Detroit Medical Center - Cardiovascular Institute

Detroit, Michigan, 48201, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Bryan Heart LGH

Lincoln, Nebraska, 69506, United States

Location

UMDNJ

Newark, New Jersey, 07103, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

The Lindner Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Trinity Clinic

Tyler, Texas, 75701, United States

Location

Inova Heart & Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Universitätsmedizin Göttingen

Hanover, Göttingen, 37075, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

Charité Berlin - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité Campus-Virchow-Klinikum

Berlin, 13353, Germany

Location

ASKLEPIOS Klinik St. Georg

Hamburg, 20099, Germany

Location

UKE - Universitäres Herzzentrum GmbH

Hamburg, 20246, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Klinikum der Univ. München - Grosshadern

München, 81377, Germany

Location

Related Publications (6)

• 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.

  PMID: 21315216 BACKGROUND

• 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.

  PMID: 18926146 BACKGROUND

• 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.

  PMID: 17018340 BACKGROUND

• 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.

  PMID: 21872139 BACKGROUND

• 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.

  PMID: 25285748 BACKGROUND

• 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.

  PMID: 29754812 BACKGROUND

Related Links

• Impulse Dynamics Website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sr. Director, Clinical and Data Operations
• Organization: Impulse Dynamics (USA) Inc

angelas@impulse-dynamics.com

8453592389

Study Officials

• Daniel Burkhoff, MD, PhD

  Impulse Dynamics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2011
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Locations

DE (9); CZ (1); US (32)