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

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ClinicalTrials.gov Identifier: NCT03102437
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics

March 23, 2017
April 5, 2017
August 14, 2018
July 1, 2017
August 15, 2018   (Final data collection date for primary outcome measure)
SADEs [ Time Frame: 6 Months ]
Serious Adverse Device Events
Not Provided
Complete list of historical versions of study NCT03102437 on ClinicalTrials.gov Archive Site
  • KCCQ [ Time Frame: 6 Months ]
    Kansas City Cardiomyopathy Questionnaire
  • NYHA [ Time Frame: 6 Months ]
    New York Heart Association classification
Not Provided
Not Provided
Not Provided
 
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%
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
Continued Access
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heart Failure
  • Congestive Heart Failure
  • Chronic Heart Disease
  • CHF
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.
Experimental: Optimizer Smart System
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
Intervention: Device: Optimizer Smart System
Abraham WT, Lindenfeld J, Reddy VY, Hasenfuss G, Kuck KH, Boscardin J, Gibbons R, Burkhoff D; FIX-HF-5C Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: study rationale and design. J Card Fail. 2015 Jan;21(1):16-23. doi: 10.1016/j.cardfail.2014.09.011. Epub 2014 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
Not Provided
August 15, 2018
August 15, 2018   (Final data collection date for primary outcome measure)

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 have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.
  7. 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.
  8. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
  9. Subjects who have had a myocardial infarction within 90 days of enrollment.
  10. Subjects who have mechanical tricuspid valve.
  11. Subjects who have a Left Ventricular Assist Device or prior heart transplant.
  12. Subjects on dialysis.
  13. Subjects who are participating in another experimental protocol.
  14. Subjects who are unable to provide informed consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Angela Stagg 845-359-2389 ext 206 angelas@impulse-dynamics.com
United States
 
 
NCT03102437
CP OPT2017-004
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: No
Impulse Dynamics
Impulse Dynamics
Not Provided
Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics
Impulse Dynamics
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP