NCT02880683

Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: NeuroTronik Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cardiac Output, Low

Interventions

Type	Name	Description
DEVICE	NeuroTronik CANS Therapy System

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-08-26
• Last updated: 2016-10-13

Locations

1 site across 1 country: Paraguay