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The Federal Joint Committee (G-BA) released guideline for co-funded trial to create evidence about the use of implanted sensors for the treatment of NYHA III heart failure patients
The pulmonary artery pressure in heart failure patients with marked limitation in activity due to symptoms (NYHA class III) is commonly measured using non-invasive monitoring methods. The Federal Joint Committee (G-BA) sees a potential in implanted sensors to optimize the treatment of heart failure. However, the evidence is currently insufficient to show a benefit of the method.
The G-BA has approved the conduction of a trial study according to §137e of the Social Code Book V. This paragraph regulates the generation of evidence of potential treatment methods troughs the co-funded trial to provide a decision base for inclusion into the statutory health benefit catalog.
The trial procedure was initiated by a successful application submitted by the manufacturer Abbott for their product “CardioMEMS™ HF System” in early 2016. On October 19th 2017, the G-BA decided on a guideline defining the following key points of the planned trial:
- Study type: Randomized controlled trial
- Intervention: Sensor implanted in pulmonary artery
- Control: Monitoring though selfmeasurement and transmission of at least body weight, blood pressure and the detection of symptoms
- Study population: 560 heart failure patients with NYHA class III
- Primary endpoints measured: Combined outcome of allcause mortality and unplanned heart failure-related hospitalizations
- Duration: 34 years
The study will be conducted and evaluated by an independent research institute chosen through a public invitation to tender. The manufacturer will carry the biggest part of the costs for the conduction and evaluation of the trial, which are estimated at about 1.8 - 3.0 million euros.
Once the results of the trial are available, the G-BA will evaluate the evidence and decide about the inclusion of implanted sensors into the health benefits catalog of the German statutory health insurance. In case of a positive decision, the method is categorized as reimbursable both for in- and out-patient settings.
The trial guideline, as well as related documents, are available in German here.
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