- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339310
Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System (FIX-HF-5C2)
January 13, 2020 updated by: Impulse Dynamics
FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bochum, Germany, 44789
- University Hospital gGmbH Bergmannsheil
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Arizona
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Mesa, Arizona, United States, 85206
- Chan Heart Rhythm Institute
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Mesa, Arizona, United States, 85206
- Southwest Cardiology Associates
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Phoenix, Arizona, United States, 85032
- Cardiovascular Consultants
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Scottsdale, Arizona, United States, 85251
- Arizona Arrhythmia Consultants
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Tucson, Arizona, United States, 85712
- Pima Heart Physicians, PC
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Illinois
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Lexington, Illinois, United States, 40503
- Baptist Health Systems
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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Texas
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Dallas, Texas, United States, 75216
- Dallas VA Hospital
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Tyler, Texas, United States, 75701
- Christus Trinity Mother Frances
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who are 18 years of age or older
- Subject is male or a non-pregnant female
- 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 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. Angiotensin receptor -neprilysin inhibitor (ARNI) may be substituted for ACE inhibitors or ARBs and Ivabradine may also be considered in subjects with a heart rate >70bpm. 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 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.
Exclusion Criteria:
- Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg. The qualifying CPX test must be deemed adequate.
- 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 before enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
- Subjects hospitalized for heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing or subjects receiving any form of positive inotropic support within 30 days before enrollment, including continuous IV inotrope therapy.
- Subjects having a PR interval greater than 375ms.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Optimizer Smart System with 2-leads
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
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The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle.
Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
Time Frame: 24 weeks
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Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
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24 weeks
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Optimizer-device and -procedure related complication rate
Time Frame: 24 weeks
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Subjects experiencing an Optimizer device- or procedure-related complication through the 24-week study period, as determined by an independent events committee.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Total CCM delivery comparing 2 and 3-lead device configurations
Time Frame: 24 weeks
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A comparison will be made between the Optimizer per-protocol groups in the FIX-HF-5C (3-lead) and FIX-HF-5C2 (2-lead) device configurations to show there is no difference between the amount of CCM therapy provided by the two device configurations.
Total CCM delivery (effective hours delivered) will be evaluated at the end of 24 weeks following the Optimizer implantation.
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David D. Gutterman, MD, Medical College of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2017
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
November 7, 2017
First Posted (Actual)
November 13, 2017
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP OPT2017-005
- FIX-HF-5C2 (Other Identifier: Impulse Dynamics)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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