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

ivaNova USA0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月15日

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•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

•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)

发起方

ivaNova USA