search
Back to results

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
Eastbourne General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurally Mediated Syncope

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 9, 2015
    Last Updated
    March 22, 2015
    Sponsor
    Eastbourne General Hospital
    search

    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

    We'll reach out to this number within 24 hrs