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

Not Applicable

• Conditions: Neurally Mediated Syncope
• Interventions: Device: ROX COUPLER; Procedure: Right heart catheterisation and routine care

• Registration Number: NCT02388087
• Lead Sponsor: Eastbourne General Hospital

Brief 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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Last Update Submitted: 2015-03-22
• Last Update Posted: 2015-03-24
• Study Start: 2015-05
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention

Exclusion Criteria

• Time to first episode of syncope after randomised intervention
• Number of syncopal episodes in the first 3 months after randomised intervention.
• Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
• Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROX COUPLER	ROX COUPLER	Iliac arterio-venous anastamosis created by insertion of ROX coupler device.
ROUTINE CARE	Right heart catheterisation and routine care	Right heart catheterisation and Routine care of Neurally mediated syncope.

Primary Outcome Measures

Name	Time	Method
Absence of loss of consciousness on tilt table testing	3 months	Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention

Secondary Outcome Measures

Name	Time	Method
Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding	6 months
Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding	6 months
Time to first episode of syncope after randomised intervention	3 months
Number of syncopal episodes in the first 3 months after randomised intervention	3 months