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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