NCT03020043 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B
[Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Ele
Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B
Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip® implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5
Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Aßmus B
[Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016

CardioMEMS Registry of the Frankfurt Heart Failure Center

Clinical trial NCT03020043 - References