Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPs)
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|ClinicalTrials.gov Identifier: NCT01981590|
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : June 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: phrenic nerve stimulation
intravenously stimulating the phrenic nerve
Device: Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
- tidal volume [ Time Frame: one hour ]
To evaluate the feasibility of transvenous electrical stimulation of the phrenic nerves to elicit inspiration.
In more detail •Characterize inspiratory response to changes on stimulation parameters (electrode configuration, amplitude, frequency, and pulse width).
•Characterize other potential physiologic changes or side effects associated with transvenous nerve stimulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981590
|Stichting Catharina Ziekenhuis|
|Eindhoven, EJ, Netherlands, 5623|
|Karolinska University Hospital, Solna|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Frieder Braunschweig, MD, PhD||Karolinska Institute, department of Cardiology|