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

Primary Purpose

Heart Failure, Congestive Heart Failure, Chronic Heart Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optimizer Smart System
Sponsored by
Impulse Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Contractility Modulation, CCM, FIX-HF-5CA, Continued Access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chan Heart Rhythm Institute
  • Southwest Cardiology Associates
  • Cardiovascular Consultants
  • Arizona Arrhythmia Consultants
  • Pima Heart
  • Baptist Health Lexington
  • University of Kentucky
  • Ochsner Clinic Foundation
  • Cooper University Hospital
  • Ohio State University Wexner Medical Center
  • St. Mary Research Institute
  • Jefferson Heart Institute
  • Hospital of the University of Pennsylvania
  • Penn Presbyterian Medical Center
  • Guthrie Medical Group at Robert Packer Hospital
  • UT Southwestern Medical Center
  • CHRISTUS Trinity Mother Frances Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optimizer Smart System

Arm Description

All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2017
Last Updated
November 21, 2021
Sponsor
Impulse Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT03102437
Brief Title
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
Acronym
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%
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impulse Dynamics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
Keywords
Cardiac Contractility Modulation, CCM, FIX-HF-5CA, Continued Access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Continued Access
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimizer Smart System
Arm Type
Experimental
Arm Description
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
Intervention Type
Device
Intervention Name(s)
Optimizer Smart System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observed Mortality Comparison to the Predicted Probability of Mortality
Description
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.
Time Frame
2 years 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease. Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy. 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. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring. Subjects having a PR interval greater than 375ms. 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. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater. Subjects who have had a myocardial infarction within 90 days of enrollment. Subjects who have mechanical tricuspid valve. Subjects who have a Left Ventricular Assist Device or prior heart transplant. Subjects on dialysis. Subjects who are participating in another experimental protocol. Subjects who are unable to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Burkhoff, MD, PhD
Organizational Affiliation
Impulse Dynamics
Official's Role
Study Director
Facility Information:
Facility Name
Chan Heart Rhythm Institute
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Southwest Cardiology Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Cardiovascular Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Pima Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
St. Mary Research Institute
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Jefferson Heart Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Guthrie Medical Group at Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
CHRISTUS Trinity Mother Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

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