Neurally Mediated Syncope
Conditions
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.
Interventions
DEVICEROX COUPLER
ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
PROCEDURERight heart catheterisation and routine care
Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.
Sponsors
Eastbourne General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of syncopal episodes in the first 3 months after randomised intervention | 3 months |
| Time to first episode of syncope 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
| Measure | Time frame |
|---|---|
| Change in exercise capacity assessed by cardio-pulmonary exercise testing after intervention compared to baseline. | 3 and 6months |
| Changes in echocardiographic parameters following intervention compared to baseline. | 3 and 6months |
| Heart rate variability following intervention as observed on 24 hour holter monitoring | 3 and 6 months |
Contacts
Primary ContactNeil Sulke, BSc, DM, FRCP
Backup ContactShunmugam Ragunath Shunmugam, MBBS, MRCP
Outcome results
None listed