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

Neurally Mediated Syncope Clinical Trial

— SHAM-ROX NMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02388087
• Other study ID #: SHAM-ROX NMS
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2015
• Last updated: March 22, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Eastbourne General Hospital
• Contact: Neil Sulke, BSc, DM, FRCP
• Email: neil.sulke[@]esht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability following intervention as observed on 24 hour holter monitoring		3 and 6 months	No
Other	Changes in echocardiographic parameters following intervention compared to baseline.		3 and 6months	No
Other	Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline.		3 and 6months	No
Primary	Absence of loss of consciousness on tilt table testing	Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention	3 months	No
Secondary	Time to first episode of syncope after randomised intervention		3 months	No
Secondary	Number of syncopal episodes in the first 3 months after randomised intervention		3 months	No
Secondary	Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding		6 months	No
Secondary	Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding		6 months	No