Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

NCT03102437 | Terminated Results FDA Device

• 1 other identifier: CP OPT2017-004
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Heart Failure; Congestive Heart Failure; Chronic Heart Disease; CHF

Keywords

Cardiac Contractility Modulation; CCM; FIX-HF-5CA; Continued Access

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Optimizer Smart System

EXPERIMENTAL

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

Device: Optimizer Smart System

Interventions

Optimizer Smart System DEVICE

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.

Optimizer Smart System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (17)

Chan Heart Rhythm Institute

Mesa, Arizona, 85206, United States

Location

Southwest Cardiology Associates

Mesa, Arizona, 85206, United States

Location

Cardiovascular Consultants

Phoenix, Arizona, 85027, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Pima Heart

Tucson, Arizona, 85745, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

St. Mary Research Institute

Langhorne, Pennsylvania, 19047, United States

Location

Jefferson Heart Institute

Philadelphia, Pennsylvania, 19047, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Guthrie Medical Group at Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

CHRISTUS Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year data. Upon PMA (3-lead) and PMA Supplement approval (2-lead) of the device, however, FDA and the Sponsor terminated this continued access study and a new PAS was initiated (NCT03970343). No long-term or final analysis was collected for this study.

Results Point of Contact

• Title: Angela Stagg
• Organization: Impulse Dynamics

astagg@impulsedynamics.com

18453592389

Study Officials

• Daniel Burkhoff, MD, PhD

  Impulse Dynamics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Continued Access

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: July 1, 2017
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)