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Clinical Trial Summary

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.


Clinical Trial Description

A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT02880683
Study type Interventional
Source NeuroTronik Inc.
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date September 2016

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