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%

Status: Terminated
Location: See all (17) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subjects who are 18 years of age or older

• Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.

• 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.

• Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.

• Subjects who are willing and able to return for all follow-up visits.

Locations
United States
Arizona
Chan Heart Rhythm Institute
Mesa
Southwest Cardiology Associates
Mesa
Cardiovascular Consultants
Phoenix
Arizona Arrhythmia Consultants
Scottsdale
Pima Heart
Tucson
Kentucky
Baptist Health Lexington
Lexington
University of Kentucky
Lexington
Louisiana
Ochsner Clinic Foundation
New Orleans
New Jersey
Cooper University Hospital
Camden
Ohio
Ohio State University Wexner Medical Center
Columbus
Pennsylvania
St. Mary Research Institute
Langhorne
Hospital of the University of Pennsylvania
Philadelphia
Jefferson Heart Institute
Philadelphia
Penn Presbyterian Medical Center
Philadelphia
Guthrie Medical Group at Robert Packer Hospital
Sayre
Texas
UT Southwestern Medical Center
Dallas
CHRISTUS Trinity Mother Frances Health System
Tyler
Time Frame
Start Date: July 1, 2017
Completion Date: December 16, 2019
Participants
Target number of participants: 106
Treatments
Experimental: Optimizer Smart System
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
Related Therapeutic Areas
Sponsors
Leads: Impulse Dynamics

This content was sourced from clinicaltrials.gov

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