Clinical trial NCT03102437: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
Official title: 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%
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Congestive Heart Failure
Chronic Heart Disease
CHF
Keywords: Cardiac Contractility Modulation
CCM
FIX-HF-5CA
Continued Access
Lead sponsor: Impulse Dynamics
Sponsor class: INDUSTRY
First posted: 2017-04-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Continued Access
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Observed Mortality Comparison to the Predicted Probability of Mortality
timeFrame: 2 years 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Chan Heart Rhythm Institute
state: Arizona
city: Mesa
country: United States
facility: Southwest Cardiology Associates
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Tucson
country: United States
facility: Pima Heart
state: Arizona
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Langhorne
country: United States
facility: St. Mary Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Heart Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group at Robert Packer Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Mother Frances Health System
state: Texas
Study officials:
affiliation: Impulse Dynamics
name: Daniel Burkhoff, MD, PhD
role: STUDY_DIRECTOR
References: