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Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System | Clinical Trials | Clareo Health

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Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

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%

NCT03102437•Impulse Dynamics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.
+3 more criteria

Locations (17)

Chan Heart Rhythm Institute

Mesa, Arizona, United States

Southwest Cardiology Associates

Mesa, Arizona, United States

Cardiovascular Consultants

Phoenix, Arizona, United States

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States

Pima Heart

Tucson, Arizona, United States

Baptist Health Lexington

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Cooper University Hospital

Camden, New Jersey, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Key Dates

Start Date

July 1, 2017

Primary Completion Date

December 16, 2019

Completion Date

December 16, 2019

Last Updated

November 23, 2021

Enrollment

106

ACTUAL participants

Conditions

Heart FailureCongestive Heart FailureChronic Heart DiseaseCHF

Interventions

Optimizer Smart System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

Inclusion Criteria

Exclusion Criteria

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