The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
Purpose The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins. Study Design This is a prospective, non-randomized, acute feasibility study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Stichting Catharina Ziekenhuis
Eindhoven, EJ, Netherlands
Karolinska University Hospital, Solna
Stockholm, Sweden
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)
Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less
Time frame: one hour
Number of Patients With Response to Stimulation (Tidal Volume)
Number of Patients With Response to Stimulation, defined by measured tidal volume of 200 ml or more induced by a pacing stimulus with pulse amplitude of 4 V or less
Time frame: one hour
Number of Patients With Observed Side Effects
Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation
Time frame: From procedure to 2-4 weeks post-procedure
Number of Observed Side Effects
All observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation such as pain, hiccup, skeletal muscular tremor, nausea, and sinus node activation
Time frame: From procedure to 2-4 weeks post-procedure
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