The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study — SHAM-ROX NMS  

Neurally Mediated Syncope Clinical Trial

Official title: The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.

Clinical Trial Description

Neurally mediated syncope (NMS) is a debilitating condition, with no proven therapeutic measures. The ROX coupler is a device used to create an Iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. The haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce NMS.

This a randomised controlled study to evaluate the effect of Iliac arterio-venous anastamosis in patients with neurally mediated syncope. The Head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with NMS. Participants with tilt test proven NMS will be eligible for the study ( if they satisfy all other eligibility criteria). Participants will be randomised to ROX coupler intervention or standard therapy. The primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Neurally Mediated Syncope
• Syncope

• NCT number: NCT02388087
• Study type: Interventional
• Source: Eastbourne General Hospital
• Contact: Neil Sulke, BSc, DM, FRCP
• Email: neil.sulke@esht.nhs.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2015
• Completion date: December 2016