SHAM-ROX NMS: The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Absence of loss of consciousness on tilt table testing [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
- Time to first episode of syncope after randomised intervention [3 months]
- Number of syncopal episodes in the first 3 months after randomised intervention [3 months]
- Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding [6 months]
- Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding [6 months]
Other Outcome Measures
- Heart rate variability following intervention as observed on 24 hour holter monitoring [3 and 6 months]
- Changes in echocardiographic parameters following intervention compared to baseline. [3 and 6months]
- Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline. [3 and 6months]
Eligibility Criteria
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:
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Time to first episode of syncope after randomised intervention
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Number of syncopal episodes in the first 3 months after randomised intervention.
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Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
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Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eastbourne General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHAM-ROX NMS