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
|Condition or disease||Intervention/treatment||Phase|
|Neurally Mediated Syncope||Device: ROX COUPLER Procedure: Right heart catheterisation and routine care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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
- Time to first episode of syncope after randomised intervention [ Time Frame: 3 months ]
- Number of syncopal episodes in the first 3 months after randomised intervention [ Time Frame: 3 months ]
- Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding [ Time Frame: 6 months ]
- Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding [ Time Frame: 6 months ]
- Heart rate variability following intervention as observed on 24 hour holter monitoring [ Time Frame: 3 and 6 months ]
- Changes in echocardiographic parameters following intervention compared to baseline. [ Time Frame: 3 and 6months ]
- Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline. [ Time Frame: 3 and 6months ]
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
|Contact: Neil Sulke, BSc, DM, FRCPemail@example.com|
|Contact: Shunmugam Ragunath Shunmugam, MBBS, MRCPfirstname.lastname@example.org|