Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

Heart Failure Clinical Trial

— FIX-HF-5CA  

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%

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03102437
• Other study ID #: CP OPT2017-004
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 16, 2019

Study information

• Verified date: February 2021
• Source: Impulse Dynamics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CHF
• Chronic Heart Disease
• Congestive Heart Failure
• Heart Diseases
• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	St. Mary Research Institute	Langhorne	Pennsylvania
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Chan Heart Rhythm Institute	Mesa	Arizona
United States	Southwest Cardiology Associates	Mesa	Arizona
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Jefferson Heart Institute	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Cardiovascular Consultants	Phoenix	Arizona
United States	Guthrie Medical Group at Robert Packer Hospital	Sayre	Pennsylvania
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona
United States	Pima Heart	Tucson	Arizona
United States	CHRISTUS Trinity Mother Frances Health System	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Impulse Dynamics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed Mortality Comparison to the Predicted Probability of Mortality	The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year observed mortality data and comparing that to the predicted probability of mortality derived from two validated heart failure models [MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and SHFM (Seattle Heart Failure Model)]. The objective was to show that the observed prevalence of mortality was not worse than the derived predicted probability of mortality. Upon PMA and PMA Supplement approval of the device, however, FDA and the Sponsor stopped this 5CA study and a new PAS was initiated (NCT03970343). No long-term mortality data or final analysis was collected for this study.	2 years 6 months