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Left Ventricular (LV) Systolic Dysfunction / Non Ischemic Cardiomyopathy / Subcutaneous cardiac microcurrent treatment · Interventional Study
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned interventional trial of a subcutaneous cardiac microcurrent device in patients with heart failure and reduced ejection fraction, with LVEF change at 6 months as the primary outcome. No results are posted in this registry record; the study is actively recruiting.
Interventional, Non Randomized, Parallel, Open label, Other purpose. Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy; age from 18 Years; to 75 Years. Intervention: Group 1: Sub-Q implantation; Group 2: Sub-Q implantation. n = 22. 4 sites: Bosnia and Herzegovina, Serbia.
This is a planned interventional trial of a subcutaneous cardiac microcurrent device in patients with heart failure and reduced ejection fraction, with LVEF change at 6 months as the primary outcome. No results are posted in this registry record; the study is actively recruiting.
This is a registry record with no results posted; no efficacy, safety, or tolerability data are reported.
This record documents a planned early-stage evaluation of a novel subcutaneous device for symptomatic heart failure. Clinicians should await publication of results before considering any clinical implications.
This is a clinical trial registry record with no results posted; it describes a planned interventional study of a novel cardiac device with an estimated sample of 22 participants and a 6-month primary endpoint.
As stated by the source record.
Quoted from the source exactly as published.
This record documents a planned early-stage evaluation of a novel subcutaneous device for symptomatic heart failure. Clinicians should await publication of results before considering any clinical implications.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06920030). This is a study registration, not published results. Lead sponsor: Berlin Heals GmbH. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 22 participants (ESTIMATED). Conditions: Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction, Non-ischemic Cardiomyopathy. Interventions: DEVICE: Subcutaneous cardiac microcurrent treatment; DEVICE: Subcutaneous cardiac microcurrent treatment. Primary outcome measures: Left ventricular ejection fraction (LVEF) change from baseline , 6 months. Brief summary: Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \>40% and \<50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management. The device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.