Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:July 1, 2017
End Date:January 15, 2020
Contact:Angela Stagg
Email:angelas@impulse-dynamics.com
Phone:845-359-2389

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FIX-HF-5CA: Continued Access Protocol for the Evaluation of the 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 Continued Access study of the Optimizer Smart
System with CCM therapy.

The Continued Access study is a prospective, non-randomized, multi-center study designed to
allow controlled access to the Optimizer Smart System until the PMA order has been issued by
the FDA.

Inclusion Criteria:

1. Subjects who are 18 years of age or older

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:

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

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

7. 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.

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

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

10. Subjects who have mechanical tricuspid valve.

11. Subjects who have a Left Ventricular Assist Device or prior heart transplant.

12. Subjects on dialysis.

13. Subjects who are participating in another experimental protocol.

14. Subjects who are unable to provide informed consent.
We found this trial at
17
sites
Philadelphia, Pennsylvania 19107
Principal Investigator: Steven Roberts, MD
Phone: 215-710-2000
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Ross Zimmer, MD
Phone: 215-662-4214
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Andrea Russo, MD
Phone: 856-669-8847
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Rami Kahwash, MD
Phone: 614-247-7133
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: James Daniels, MD
Phone: 214-648-9261
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Langhorne, Pennsylvania 19047
Principal Investigator: Heath Saltzman, MD
Phone: 215-710-4586
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Lexington, Kentucky 40503
Principal Investigator: Gery Tomassoni, MD
Phone: 859-260-6429
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Aaron Hesselson, MD
Phone: 859-218-1644
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Mesa, Arizona 85206
Principal Investigator: Rodrigo Chan, MD
Phone: 480-773-2220
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140 South Power Road
Mesa, Arizona 85206
Principal Investigator: Charles Jost, MD
Phone: 602-460-5390
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New Orleans, Louisiana 70121
Principal Investigator: Freddy Abi-Samra, MD
Phone: 504-703-2962
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Philadelphia, Pennsylvania
Principal Investigator: Ross Zimmer, MD
Phone: 215-662-8562
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Phoenix, Arizona 85032
Principal Investigator: Andy Tran, MD
Phone: 602-652-8761
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Sayre, Pennsylvania 18840
Principal Investigator: Pramod Deshmukh, MD
Phone: 570-887-6071
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Scottsdale, Arizona 85251
Principal Investigator: Thomas Mattioni, MD
Phone: 480-323-1046
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Tucson, Arizona 85718
Principal Investigator: Darren F. Peress, MD
Phone: 520-465-1849
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800 East Dawson Street
Tyler, Texas 75701
Principal Investigator: Stan Weiner, MD
Phone: 903-606-8846
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