Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System (FIX-HF-5CA)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Congestive Heart Failure; CHF; Chronic Heart Disease
• Intervention / Treatment: Device: Optimizer Smart System

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Chan Heart Rhythm Institute
    • Mesa, Arizona, United States, 85206
      • Southwest Cardiology Associates
    • Phoenix, Arizona, United States, 85027
      • Cardiovascular Consultants
    • Scottsdale, Arizona, United States, 85251
      • Arizona Arrhythmia Consultants
    • Tucson, Arizona, United States, 85745
      • Pima Heart
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Research Institute
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
    • Philadelphia, Pennsylvania, United States, 19047
      • Jefferson Heart Institute
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group at Robert Packer Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimizer Smart System; All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Impulse Dynamics
• Investigators: Study Director: Daniel Burkhoff, MD, PhD, Impulse Dynamics

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac Contractility Modulation; CCM; Continued Access; FIX-HF-5CA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Failure; Heart Diseases
• Other Study ID Numbers: CP OPT2017-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes