Clinical trial NCT03339310: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System
Official title: FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Congestive Heart Failure
Chronic Heart Disease
CHF
Keywords: CCM Therapy
2-Lead
FIX-HF-5C2
Optimizer
Lead sponsor: Impulse Dynamics
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Optimizer Smart System
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads

Detailed description: This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.

Eligibility criteria: Inclusion Criteria:

* Subjects who are 18 years of age or older
* Subject is male or a non-pregnant female
* Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
* Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
* Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Angiotensin receptor -neprilysin inhibitor (ARNI) may be substituted for ACE inhibitors or ARBs and Ivabradine may also be considered in subjects with a heart rate \>70bpm. Stable is defined as no more than a 100% increase or 50% decrease in dose.
* Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device unless the patient refuses to undergo the implantation of such device for personal reasons.
* Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

* Subjects whose baseline peak VO2 is \<9 or \>20 ml O2/min/kg. The qualifying CPX test must be deemed adequate.
* Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
* Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days before enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
* Subjects hospitalized for heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing or subjects receiving any form of positive inotropic support within 30 days before enrollment, including continuous IV inotrope therapy.
* Subjects having a PR interval greater than 375ms.
* Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
* 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 prior heart transplant.
* Subjects on dialysis.
* Subjects who are participating in another experimental protocol.
* Subjects who are unable to provide informed consent.

Primary outcomes:
measure: Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
timeFrame: 24 weeks
measure: Optimizer-device and -procedure related complication rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Total CCM delivery comparing 2 and 3-lead device configurations
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Chan Heart Rhythm Institute
state: Arizona
city: Mesa
country: United States
facility: Southwest Cardiology Associates
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians, PC
state: Arizona
city: Lexington
country: United States
facility: Baptist Health Systems
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Dallas
country: United States
facility: Dallas VA Hospital
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Mother Frances
state: Texas
city: Bochum
country: Germany
facility: University Hospital gGmbH Bergmannsheil
Study officials:
affiliation: Medical College of Wisconsin
name: David D. Gutterman, MD
role: STUDY_DIRECTOR
References:
citation: Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8.