Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2019-10-30

Brief Summary

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

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Detailed Description

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

Conditions

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Heart Failure Congestive Heart Failure Chronic Heart Disease CHF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Optimizer Smart System

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optimizer Smart System with 2-leads

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

Group Type EXPERIMENTAL

Optimizer Smart System with 2-leads

Intervention Type DEVICE

The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.

Interventions

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Optimizer Smart System with 2-leads

The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.

Intervention Type DEVICE

Other Intervention Names

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Optimizer Smart System

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No