Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
NCT ID: NCT03102437
Last Updated: 2021-11-23
Study Results
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View full resultsBasic Information
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TERMINATED
NA
106 participants
INTERVENTIONAL
2017-07-01
2019-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Optimizer Smart System
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System
The Optimizer Smart 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.
Interventions
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Optimizer Smart System
The Optimizer Smart 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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
3. Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
4. Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
5. Subjects who are willing and able to return for all follow-up visits.
Exclusion Criteria
2. Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
3. Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
4. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
5. Subjects having a PR interval greater than 375ms.
6. 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.
7. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
8. Subjects who have had a myocardial infarction within 90 days of enrollment.
9. Subjects who have mechanical tricuspid valve.
10. Subjects who have a Left Ventricular Assist Device or prior heart transplant.
11. Subjects on dialysis.
12. Subjects who are participating in another experimental protocol.
13. Subjects who are unable to provide informed consent.
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Burkhoff, MD, PhD
Role: STUDY_DIRECTOR
Impulse Dynamics
Locations
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Chan Heart Rhythm Institute
Mesa, Arizona, United States
Southwest Cardiology Associates
Mesa, Arizona, United States
Cardiovascular Consultants
Phoenix, Arizona, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Pima Heart
Tucson, Arizona, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Cooper University Hospital
Camden, New Jersey, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
St. Mary Research Institute
Langhorne, Pennsylvania, United States
Jefferson Heart Institute
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Guthrie Medical Group at Robert Packer Hospital
Sayre, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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CP OPT2017-004
Identifier Type: -
Identifier Source: org_study_id