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

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ClinicalTrials.gov Identifier: NCT02388087
Recruitment Status : Unknown
Verified March 2015 by Neil Sulke, Eastbourne General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Neil Sulke, Eastbourne General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neurally Mediated Syncope Device: ROX COUPLER Procedure: Right heart catheterisation and routine care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
Study Start Date : May 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting Fistulas

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to first episode of syncope after randomised intervention [ Time Frame: 3 months ]
  2. Number of syncopal episodes in the first 3 months after randomised intervention [ Time Frame: 3 months ]
  3. Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding [ Time Frame: 6 months ]
  4. Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding [ Time Frame: 6 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388087


Contacts
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Contact: Neil Sulke, BSc, DM, FRCP neil.sulke@esht.nhs.uk
Contact: Shunmugam Ragunath Shunmugam, MBBS, MRCP r.shunmugam@nhs.net

Sponsors and Collaborators
Eastbourne General Hospital
More Information
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Responsible Party: Neil Sulke, Dr, Eastbourne General Hospital
ClinicalTrials.gov Identifier: NCT02388087    
Other Study ID Numbers: SHAM-ROX NMS
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases