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

Completed · Not applicable

Conditions studied: NYHA Class III Heart Failure, NYHA Class IV Heart Failure

In brief

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.

Key facts

Study ID

NCT01381172

Run by

Impulse Dynamics

People needed

160

Starts

2011-01-01

Expected to finish

2019-03-19

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subjects who are unable to provide informed consent.

Where it is running

• 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

Full record on ClinicalTrials.gov

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