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

March 22, 2015 updated by: Neil Sulke, Eastbourne General Hospital
The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ROX COUPLER
Iliac arterio-venous anastamosis created by insertion of ROX coupler device.
Device: ROX COUPLER
ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
SHAM_COMPARATOR: ROUTINE CARE
Right heart catheterisation and Routine care of Neurally mediated syncope.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of loss of consciousness on tilt table testing
Time Frame: 3 months
Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention
3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Heart rate variability following intervention as observed on 24 hour holter monitoring
Time Frame: 3 and 6 months
3 and 6 months
Changes in echocardiographic parameters following intervention compared to baseline.
Time Frame: 3 and 6months
3 and 6months
Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline.
Time Frame: 3 and 6months
3 and 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastbourne General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (ESTIMATE)

March 13, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 22, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHAM-ROX NMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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