The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study (SHAM-ROX NMS)
Primary Purpose
Neurally Mediated Syncope
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ROX COUPLER
Right heart catheterisation and routine care
Sponsored by
About this trial
This is an interventional treatment trial for Neurally Mediated Syncope
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
ROX COUPLER
ROUTINE CARE
Arm Description
Iliac arterio-venous anastamosis created by insertion of ROX coupler device.
Right heart catheterisation and Routine care of Neurally mediated syncope.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02388087
First Posted
March 9, 2015
Last Updated
March 22, 2015
Sponsor
Eastbourne General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02388087
Brief Title
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
Acronym
SHAM-ROX NMS
Official Title
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastbourne General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurally Mediated Syncope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROX COUPLER
Arm Type
Active Comparator
Arm Description
Iliac arterio-venous anastamosis created by insertion of ROX coupler device.
Arm Title
ROUTINE CARE
Arm Type
Sham Comparator
Arm Description
Right heart catheterisation and Routine care of Neurally mediated syncope.
Intervention Type
Device
Intervention Name(s)
ROX COUPLER
Intervention Description
ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
Intervention Type
Procedure
Intervention Name(s)
Right heart catheterisation and routine care
Intervention Description
Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.
Primary Outcome Measure Information:
Title
Absence of loss of consciousness on tilt table testing
Description
Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to first episode of syncope after randomised intervention
Time Frame
3 months
Title
Number of syncopal episodes in the first 3 months after randomised intervention
Time Frame
3 months
Title
Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
Time Frame
6 months
Title
Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Heart rate variability following intervention as observed on 24 hour holter monitoring
Time Frame
3 and 6 months
Title
Changes in echocardiographic parameters following intervention compared to baseline.
Time Frame
3 and 6months
Title
Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline.
Time Frame
3 and 6months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Sulke, BSc, DM, FRCP
Email
neil.sulke@esht.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Shunmugam Ragunath Shunmugam, MBBS, MRCP
Email
r.shunmugam@nhs.net
12. IPD Sharing Statement
Learn more about this trial
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
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