NCT02388087

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Eastbourne General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neurally Mediated Syncope

Interventions

Type	Name	Description
DEVICE	ROX COUPLER	ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
PROCEDURE	Right heart catheterisation and routine care	Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2015-03-13
• Last updated: 2015-03-24