AUTONOMIC REGULATION THERAPY TO ENHANCE MYOCARDIAL FUNCTION AND REDUCE PROGRESSION OF HEART FAILURE WITH REDUCED EJECTION FRACTION (ANTHEM-HFrEF)

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

4 Currently in sinus rhythm (extrasystoles are allowed; CRT or CRT-D recipients
who have been receiving CRT for at least 6 months, and ICD and pacemaker
recipients, may enter the study; paroxysmal and persistent atrial fibrillation
are allowed if the patient is currently in sinus rhythm5. Guideline Directed
Medical Therapy for at least 4 weeks6. Stable symptomatic NYHA III; or II with
a HF hospitalization within the previous 12 months7. Left ventricular ejection
fraction (LVEF) <=< 35% (verified by central core lab) and left ventricular
end-diastolic diameter (LVEDD) <8.0 cm,8. NT-proBNP > 800 pg/mL as determined
by the core-laboratory, as long as the patient reports having experienced no
signs or symptoms of atrium fibrilation during the 3 days preceding the
NT-proBNP measurements . 10. Baseline 6 Minute Walk Test (6MWT) between 150 and
450 meters

Exclusion Criteria

1. Refractory symptomatic hypotension (SBP <80 mmHg)2. Pacemaker therapy that
utilizes unilateral ventricular pacing with a right ventricular lead for
complete AV block
3. Currently implanted with VNS, BAT or VAD4.Persistent atrial fibrillation or
ablation of atrial fibrillation in the past 3 months5. Within last 6 weeks:
Pacemaker or ICD implant
CV hospitalization (including TIA and syncope)
Epigastric or upper gastrointestinal bleeding6. Scheduled, or likely to be
scheduled within the next 3 months for
a. Cardiac contractility modulation (CCM), CRT, VNS, BAT or other device
implantation for improving ventricular function; or non-cardiac organ transplant
b. A therapeutic cardiovascular procedure (including but not limited to PCI,
CABG, valve replacement or repair, aorta surgery, or ablation for arrhythmia
management7. Heart failure of non-ischemic origin for less than 6 months, or
due to congenital heart disease, hypertrophic obstructive cardiomyopathy, or
infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint will be a composite of cardiovascular mortality<br /><br>or heart failure hospitalization, based on time to first event after<br /><br>randomization, as adjudicated by an independent Clinical Events Committee<br /><br>(CEC). The primary safety endpoint will consist of the event-free rate, through<br /><br>90 days after VITARIA implantation, from all VITARIA system-related and VITARIA<br /><br>implantation-related<br /><br>serious adverse events.</p><br>

Secondary Outcome Measures